NOVEMBER 2007
WEEK ENDING NOVEMBER 3
PRODUCT
a)
Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with
tined tip and right ventricular (RV) defibrillation coil
electrode. Sterile. This lead is designed for pacing,
sensing, cardioversion and defibrillation therapies,
b)
Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular
lead with right ventricular (RV) defibrillation coil
electrode. Sterile. This lead is designed for
pacing, sensing, cardioversion and defibrillation therapies,
c) Medtronic Sprint Fidelis 6948 Steroid eluting,
quadripolar,
ventricular lead with tined tip and right ventricular
(RV) / Superior Vena Cava (SVC) defibrillation coil
electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion
and defibrillation therapies,
d)
Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in,
ventricular lead with right ventricular (RV) / Superior
Vena Cava (SVC) defibrillation coil electrodes. Sterile.
This lead is designed for pacing, sensing, cardioversion and defibrillation therapies,
CODE
All codes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Rhythm
Management, Minneapolis, MN,
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR.
REASON
Medtronic
Cardiac Rhythm Disease Management has voluntarily suspended worldwide
distribution of the Sprint Fidelis family of defibrillation leads because of the
potential for lead fractures. In addition, the company recommends against new
implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949).
Medtronic, its Independent Physician Quality Panel, and the President of the
Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic
replacement of Sprint Fidelis leads, as the risks of removal or insertion of
another lead exceed the small risk to patients of a lead fracture. Medtronic has
provided patient management recommendations that should reduce risks in the
affected population and recommends that patients with questions consult their
physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This
decision is based on a variety of factors that, when viewed together, indicate
that suspending distribution is the appropriate action. Lead fractures may
present clinically as audible alerts, inappropriate shocks and/or loss of
output.
VOLUME OF PRODUCT IN COMMERCE Approximately
235,000 devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component,
b) Smith + Nephew, Birmingham Hip Resurfacing,
Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant
component,
c) Smith + Nephew,
Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component,
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
50 mm cup Ref.: 74120150. Hip implant component,
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
52 mm cup Ref.: 74120152. Hip implant component,
f) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
54 mm cup Ref.: 74120154. Hip implant component
g) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
56 mm cup Ref.: 74120156. Hip implant component,
h) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
58 mm cup Ref.: 74120158. Hip implant component,
i) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
60 mm cup Ref.: 74120160. Hip implant component,
j) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
62 mm cup Ref.: 74120162. Hip implant component,
k) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular
Cup, 64 mm cup Ref.: 74120164. Hip
implant component,
l) Smith + Nephew, Birmingham Hip
Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166.
Hip implant component,
m) Smith + Nephew, Birmingham
Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.:
74120250. Hip implant component
n) Smith + Nephew,
Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component,
o) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54
mm cup Ref.: 74120254. Hip implant component,
p) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
58 mm cup Ref.: 74120258. Hip implant component,
q) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup,
62 mm cup Ref.: 74120262. Hip implant component,
CODE
a) Lot Numbers: 64739, 66135, 66857,
67626, 67663, 67958, 67860;
b) Lot Numbers: 66608, 65074, 65569, 66778,
66780, 64803;
c) Lot Numbers: 66781, 63743, 64110, 64498, 65674;
d)
Lot Numbers: 65654, 64188, 67081, 67582, 67421, 67945, 68035;
e) Lot Numbers:
64797, 64798, 64846, 65084, 67553, 67555, 67557, 67871, 67388, 67589, 67706;
f) Lot Numbers: 65543, 66655,
63286, 63765, 64773, 65676, 66861, 67510;
g) Lot Numbers: 64767, 65679,
65943, 63452, 64595, 64800, 64840, 64841, 64856, 64858,
65004, 65005, 65075, 65078, 65080, 65082, 65478, 65529, 65533, 65942, 65946, 66109, 66131, 66621, 66878, 67220, 67346;
h)
Lot Numbers: 65655, 64496, 65081, 66111, 67874, 67477, 67925, 67940;
i) Lot
Numbers: 64599, 65540, 65501, 65660, 66862, 66862, 66886, 66926,
67062, 67218, 67223, 67345, 67560, 67576, 67886, 67887,
67923, 68299, 68302, 67704, 67944;
j) Lot Numbers: Lot
Numbers: 64740, 64957, 65657, 67343, 67580, 67971;
k) Lot Numbers: 64178,
65670, 66424, 66802;
l) Lot Numbers: 66700, 67558, 67630, 67733;
m) Lot
Numbers: 66612, 66999;
n) Lot Number 66925;
o) Lot Number 64868;
p) Lot
Number 66949;
q) Lot Number 67216
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smith and Nephew, Inc., Memphis,
TN,
Manufacturer: Finsbury Orthopaedics, Leatherhead, UK.
REASON
The carton label may not
reflect the correct size of the Acetabular cup.
VOLUME OF PRODUCT IN
COMMERCE 176 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Urinary
Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml
Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For
Single Use Only,
CODE Lot # 20070423
(500-D), and Lot #20070420 (1000-D)
RECALLING
FIRM/MANUFACTURER Remington Medical, Inc., Alpharetta, GA,
REASON
Sterility, inadequate -- Pathway may not
be sterile as labeled.
VOLUME OF PRODUCT IN
COMMERCE 45,000
units
DISTRIBUTION Nationwide
PRODUCT HeartStart
XL Defibrillator/Monitor, Model: M4735A, CODE
S/N's: Lot
numbers(s) or serial number(s) US00453446 US00453452 US00453458 US00453459 US00453460 US00453461
US00453463 US00453465 US00453466 US00453471 US00453472 US00453475 US00453477
US00453479 US00453486 US00453487 US00453488 US00453489 US00453490 US00453491
US00453492 US00453513 US00453514 US00453515 US00453516 US00453517 US00453541
US00453542 US00453543 US00453544 US00453545 US00453546 US00453547 US00453548
US00453549 US00453550 US00453552 US00453553 US00453564 US00453565 US00453566
US00453596 US00453597 US00453598 US00453599 US00453601 US00453602 US00453603
US00453604 US00453607 US00453609 US00453610 US00453611 US00453613 US00453614
US00453615 US00453616 US00453617 US00453618 US00453619 US00453621 US00453622
US00453623 US00453624 US00453631 US00453634 US00453635 US00453636 US00453637
US00453638 US00453640 US00453641 US00453642 US00453645 US00453646 US00453647
US00453648 US00453649 US00453650 US00453651 US00453652 US00453653 US00453654
US00453655 US00453656 US00453657 US00453658 US00453659 US00453660 US00453661
US00453662 US00453663 US00453664 US00453666 US00453667 US00453668 US00453669
US00453670 US00453671 US00453672 US00453673 US00453674 US00453675 US00453676
US00453677 US00453678 US00453679 US00453691 US00453692 US00453693 US00453694
US00453695 US00453696 US00453712 US00453714 US00453715 US00453716 US00453717
US00453721 US00453723 US00453724 US00453725 US00453726 US00453730 US00453731
US00453732 US00453733 US00453734 US00453735 US00453736 US00453737 US00453738
US00453739 US00453740 US00453742 US00453744 US00453745 US00453746 US00453747
US00453748 US00453749 US00453751 US00453752 US00453753 US00453754 US00453755
US00453758 US00453759 US00453760 US00453766 US00453767 US00453796 US00453797
US00453798 US00453799 US00453800 US00453801 US00453802 US00453803 US00453804
US00453805 US00453806 US00453807 US00453808 US00453809 US00453810 US00453811
US00453812 US00453813 US00453814 US00453815 US00453816 US00453817 US00453818
US00453819 US00453820 US00453821 US00453822 US00453823 US00453824 US00453825
US00453826 US00453827 US00453828 US00453829 US00453830 US00453831 US00453832
US00453833 US00453834 US00453835 US00453836 US00453847 US00453849 US00453850
US00453852 US00453853 US00453854 US00453855 US00453856 US00453857 US00453861
US00453863 US00453864 US00453865 US00453866 US00453867 US00453868 US00453869
US00453870 US00453871 US00453872 US00453873 US00453874 US00453907 US00453908
US00453909 US00453910
RECALLING
FIRM/MANUFACTURER Philips, Medical Systems, Andover, MA
REASON
Inadequate shipping package causing
damage to control boards resulting in unit failure. Failure to deliver therapy
(defibrillation, pacing or cardioversion) may occur as a result of undetected
damage to the PCB assembly.
VOLUME OF PRODUCT IN
COMMERCE 147
boards
DISTRIBUTION Internationally
PRODUCT BD
Microkeratome K3000 and K4000; Catalog Number: 378660,
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER Becton Dickinson and Company, Waltham, MA
REASON
Microkeratome blade may stop oscillating
and transverse the eye causing injury to the cornea.
VOLUME OF
PRODUCT IN COMMERCE 256
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster
Screw Holes. Hip prosthesis component. Sterile, Made in
USA, b) HA Solid Back Acetabular Shell; Arc Deposited
HA Coated Included Dome hole Plug; Hip prosthesis
component. Sterile; made in USA,
CODE
a) Catalog # Description Lot code
542-11-46D TRIDENT PSL HA CLUSTER 46mm R3YMHD; 542-11-48D
TRIDENT PSL HA CLUSTER 48mm 1PMMJD 542-11-48D TRIDENT PSL
HA CLUSTER 48mm 663MJD 542-11-48D TRIDENT PSL HA
CLUSTER
48mm 664MJD 542-11-50E TRIDENT PSL HA
CLUSTER 50mm 1TEMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 1TJMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 2K0MJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 32JMJD 542-11-50E TRIDENT PSL HA
CLUSTER
50mm 61YMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 626MJD
542-11-50E TRIDENT PSL HA CLUSTER 50mm 70HMJD 542-11-50E
TRIDENT PSL HA
CLUSTER 50mm 71NMJD 542-11-50E TRIDENT PSL
HA CLUSTER 50mm PYNMHD 542-11-50E TRIDENT PSL HA CLUSTER
50mm RHVMHD 542-11-50E TRIDENT PSL HA CLUSTER 50mm RHXMHD
542-11-52E TRIDENT PSL HA
CLUSTER 52mm 8R8MJD 542-11-52E
TRIDENT PSL HA CLUSTER 52mm 8RDMJD 542-11-52E TRIDENT PSL
HA CLUSTER 52mm PYVMHD 542-11-52E TRIDENT PSL HA CLUSTER
52mm REKMHD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm 0YPMJD
542-11-54F TRIDENT PSL HA CLUSTER 54mm 3HAMJD 542-11-54F
TRIDENT PSL HA CLUSTER 54mm 500MJD 542-11-54F TRIDENT PSL
HA CLUSTER 54mm 76YMJD 542-11-54F TRIDENT PSL HA
CLUSTER
54mm 7NWMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 7Y3MJD
542-11-54F TRIDENT PSL HA CLUSTER 54mm 7Y4MJD 542-11-54F
TRIDENT PSL HA CLUSTER 54mm 8HWMJD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm TK9MHD 542-11-54F TRIDENT PSL HA CLUSTER
54mm TKAMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKDMHD
542-11-54F TRIDENT PSL HA CLUSTER 54mm TKEMHD 542-11-54F
TRIDENT PSL HA
CLUSTER 54mm TKHMHD 542-11-56F TRIDENT PSL
HA CLUSTER 56mm 0PJMJD 542-11-56F TRIDENT PSL HA
CLUSTER
56mm 0PMMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 81AMJD
542-11-56F TRIDENT PSL HA
CLUSTER 56mm 81DMJD 542-11-56F
TRIDENT PSL HA CLUSTER 56mm T6KMHD 542-11-58G TRIDENT PSL
HA CLUSTER 58mm 518MJD 542-11-62H TRIDENT PSL HA CLUSTER
62mm 2PMMJD 542-11-62H TRIDENT PSL HA
CLUSTER 62mm 7D2MJD
542-11-68I TRIDENT PSL HA
CLUSTER 68mm 3AWMJD 542-11-72J
TRIDENT PSL HA CLUSTER 72mm 1WNMJD
b) 540-11-52E TRIDENT PSL HA SOLID BACK
52mm 8NKMJD 540-11-54F TRIDENT PSL HA SOLID BACK 54mm
3H7MJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 78AMJD
540-11-58G TRIDENT PSL HA SOLID BACK 58mm 9T9MJD
540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4THMJD 540-
11-66I TRIDENT PSL HA SOLID BACK 66mm 4TJMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm RLKMHD 540-11-72J TRIDENT PSL HA
SOLID BACK 72mm 1WNMJD
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ
REASON
Stryker Orthopaedics had identified that
specific lots of Trident PSL Acetabular shells may have a dimensional
discrepancy. The deviation regarding the difference in wall thickness will
increase the gap between the shell and liner on one side and will decrease the
gap between shell and liner on the opposing side, resulting in
interference.
VOLUME OF PRODUCT IN COMMERCE 142 units
DISTRIBUTION Nationwide and
Brazil
PRODUCT
Steris
QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes
to processing trays) The malfunctioning piece of the quick connect component is
adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port
of the endoscope.,
CODE
C041782,
C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749,
3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261,
3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160,
3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357,
3895661, 3900198
RECALLING FIRM/MANUFACTURER Steris
Corporation Hopkins Facility, Mentor, OH,
REASON Loose or missing adaptor. The center
insert of the adaptor #6 restrictor could become loose and/or come out of the
adaptor’s housing. The absence of adaptor #6’s center insert may affect the
sterilization process of the attached endoscope.
VOLUME OF PRODUCT IN
COMMERCE 391 Quick
Connects
DISTRIBUTION Nationwide and Internationally
PRODUCT
Biomet
Orthopedics Apical Hole Plug, 3/8 – 24 threaded, TI-6AL-4V alloy, sterile;
REF123741,
CODE Lot:
522080
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw,
IN, REASON Incorrect or lack of
threading: The plug component was manufactured incorrectly and does not fit with
the screw hole as intended.
VOLUME OF PRODUCT IN
COMMERCE 5
units
DISTRIBUTION MA
PRODUCT
a)
Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile
EO,
b) Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left
3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in
Mexico,
CODE
a) Lot #: 572191;
b)
Lot #: 559022
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific, Maple Grove, MN,
Manufacturer: Pacific Device De Mexico S A De C
V, Tijuana B C, Mexico.
REASON Missing holes: Catheters are missing the
catheter's side holes.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION NY, PA, and Japan
WEEK ENDING NOVEMBER 10
Welch Allyn AED 10 Automatic External Defibrillators
Recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.PRODUCT Bio-logic
System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and
580-VIDPOL) and assemblies (580IPCART and 580 PNCART; The Model 580-VIDPOL is
used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole
is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired
for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video,
CODE No serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bio-Logic Systems Corp.,
Mundelein, IL,
Manufacturer: TLK
Industries Inc., Palatine, IL.
REASON Bio-logic System Corp Camera Pole may
weaken and detach at the base of the telescoping camera pole during transport
causing pole to break at the welded base and fall.
VOLUME OF PRODUCT
IN COMMERCE 311 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Medtronic
Export XT Aspiration Catheter, 6F Model Numbers: G146200USB (US Distribution)
G1452006B (Outside US), CODE All lot
numbers
RECALLING FIRM/MANUFACTURER Medtronic, Inc.,
Danvers, MA,
REASON Additional Warning in Instructions for
Use for guide wire management. Complaints of wire lumen tearing during use or
band marker becoming dislodged.
VOLUME OF PRODUCT IN
COMMERCE 13,940 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)-- Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm
thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF
155364,
b) Biomet Orthopedics DCM AGC Molded Tibial
Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy,
sterile; REF 155116, CODE
a) Lot
311500; exp. 2012-02.
b) Lot 918930; exp. 2012-02.
RECALLING
FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN,
REASON
Incorrect Product -- Mislabeled as to
size. An 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm
x 80 mm.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION IA, SD, Brazil and
Chile
PRODUCT Spectra
Optia apheresis system, a blood component separator. Part No. 61000,
CODE
Serial #’s: 1P00100 to
1P00141
RECALLING FIRM/MANUFACTURER Gambro BCT, Inc.,
Lakewood, CO
REASON Under
specific conditions, apheresis machine could return up to 60 mL. of air to the
patient.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION Nationwide, Canada, Australia,
Europe
PRODUCT ReUnion
Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal
Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Product No.
5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612,
CODE
All lot codes
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ
REASON
The plasma spray may delaminate from the
proximal portion of the humeral stem.
VOLUME OF PRODUCT IN
COMMERCE 232
units
DISTRIBUTION OH
PRODUCT
a)
Brilliance CT Systems, 40 slice configuration. Computed tomography
scanner, Model No. 728231,
b) Brilliance CT Systems 64 slice configuration. Computed
tomography scanner. Model No. 728235,
CODE a) and b) Version
2.2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips
Medical Systems (Cleveland) Inc., Cleveland, OH,
Manufacturer: Philips Medical Systems
Technolo, Haifa, Israel.
REASON Two potential
artifacts may appear in some images from head scans on the Brilliance 40/64
systems. These artifacts may lead to misdiagnosis.
VOLUME OF PRODUCT
IN COMMERCE 1,037
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 UPN Number: M00513321 REF: 1332-20,
b) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps
with Needle, Sterile, 240 mm. Box of 20 UPN Number:
M00513331 REF: 1333-20,
c)
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40,
CODE
a) Lot Number: 8990184;
b)
Lot Numbers: 8984691, 9005322, 9005726, 9005727;
c) Lot Numbers: 8984687,
8984688, 8984689, 8990186, 9003394, 9003396, 9005718,
9005719, 9017283
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Boston Scientific Corporation, Marlborough, MA
Manufacturer: Boston Scientific Corporation, Global Park,
Heredia, Costa Rica.
REASON Device lacked manufacturing finishing process
resulting in scope damage.
VOLUME OF PRODUCT IN
COMMERCE 1,519 boxes
DISTRIBUTION Nationwide
and Internationally
PRODUCT Bio-Rad
Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit,
Catalog # 26174,
CODE Lot:
131BHH
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories,
Redmond, WA
REASON Incorrect
Instructions. The packages insert states to add 100L of conjugate; it should
state to add 100uL.
VOLUME OF PRODUCT IN COMMERCE 46
kits
DISTRIBUTION Nationwide
PRODUCT
a)
Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26,
b) Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30,
c) Olympus Single Use Mechanical
Lithotriptor, Model number
BML-V242QR-30,
d) Olympus Single
Use Mechanical Lithotriptor, Model number BML-201Q
CODE
a) Model number BML-V232QR-26:
Lot numbers 75K, 76K, and 77K.
b) Model number BML-V232QR-30: Lot numbers
75K, 76K, and 77K;
c) Model number BML-V242QR-30: Lot numbers 75K, 76K, and
77K;
d) Model number BML-201Q: Lot numbers 76K and 77K
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center
Valley, PA
Manufacturer:
Aomori Olympus Co Ltd, Aomori, Japan.
REASON Slider knob does not move smoothly causing the
user difficulty in advancing the coil sheath.
VOLUME OF PRODUCT IN
COMMERCE 482
units
DISTRIBUTION Nationwide
PRODUCT
Boston
Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number:
MOO1183030,Catalog Number: 18-303
CODE Lot Numbers: 9218692; 9218628;
9218451
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific Corporation, Marlborough, MA,
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland.
REASON
Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire
instead of the kit labeled 165 cm length Transend-18 guidewire.
VOLUME OF PRODUCT IN COMMERCE
153
units
DISTRIBUTION Nationwide
PRODUCT
Harleco
May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; Item #
660/75 1 liter and Item 660/85 /4 liter poly bottles,
CODE Lot: 7161, Exp. Date: 31 Jan
09
RECALLING FIRM/MANUFACTURER EMD Chemicals, Inc.,
Gibbstown, NJ
REASON Batch Out of Specifications. The Batch
(Lot) was incorrectly released after being rejected for out of specification of
high azure and eosin absorbance at the end of the run and particulate matter at
the end of the run.
VOLUME OF PRODUCT IN COMMERCE 26
units (1 liter), 1 unit (4 liter)
DISTRIBUTION US and
Canada
WEEK ENDING NOVEMBER 17
PRODUCT Welch
Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery
powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E,
970310E and 970311E;
CODE
Serial
numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005,
NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025,
NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035,
NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052,
NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092,
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NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121,
NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129,
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NA037160, NA037161, NA037162, NA037163, NA037164, NA037166, NA037167, NA037168,
NA037169, NA037170, NA037171, NA037172, NA037173, NA037174, NA037175, NA037177,
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NA037188, NA037189, NA037190, NA037193, NA037194, NA037203, NA037206, NA037207,
NA037209, NA037210, NA037213, NA037217, NA037219, NA037220, NA037221, NA037223,
NA037225, NA037228, NA037234, NA037256, NA037354, NA037499, NA037511, NA037512,
NA037513, NA037515, NA037516, NA037517, NA037518, NA037519, NA037523, NA037524,
NA037525, NA037532, NA037533, NA037534, NA037535, NA037536, NA037538, NA037539,
NA037540, NA037541, NA037542, NA037543, NA037544, NA037545, NA037546, NA037547,
NA037548, NA037549, NA037550, NA037551, NA037552, NA037553, NA037554, NA037555,
NA037556, NA037557, NA037558, NA037559, NA037560, NA037561, NA037562, NA037563,
NA037564, NA037565, NA037566, NA037567, NA037568, NA037569, NA037570, NA037571,
NA037572, NA037573, NA037574, NA037575, NA037576, NA037577, NA037578, NA037579,
NA037580, NA037581, NA037582, NA037583, NA037584, NA037585, NA037586, NA037587,
NA037588, NA037589, NA037590, NA037591, NA037592, NA037593, NA037594, NA037595,
NA037596, NA037597, NA037598, NA037599, NA037600, NA037601, NA037602, NA037603,
NA037604, NA037605, NA037606, NA037607, NA037608, NA037609, NA037610, NA037614,
NA037615, NA037616, NA037617, NA037619, NA037620, NA037621, NA037622, NA037624,
NA037625, NA037626, NA037627, NA037628, NA037629, NA037630, NA037631, NA037632,
NA037633, NA037634, NA037635, NA037636, NA037637, NA037638, NA037639, NA037640,
NA037641, NA037643, NA037644, NA037645, NA037646, NA037647, NA037648, NA037649,
NA037650, NA037651, NA037652, NA037653, NA037654, NA037655, NA037656, NA037658,
NA037659, NA037660, NA037661, NA037662, NA037663, NA037664, NA037665, NA037666,
NA037667, NA037668, NA037669, NA037670, NA037671, NA037672, NA037673, NA037674,
NA037675, NA037676, NA037677, NA037678, NA037679, NA037680, NA037681, NA037682,
NA037683, NA037684, NA037685, NA037686, NA037688, NA037691, NA037696, NA037699,
NA037700, NA037702, NA037704, NA037705, NA037706, NA037707, NA037708, NA037712,
NA037713, NA037716, NA037717, NA037719, NA037720, NA037723, NA037724, NA037725,
NA037729, NA037730, NA037731, NA037732, NA037738, NA037742, NA037743, NA037745,
NA037746, NA037747, NA037749, NA037750, NA037751, NA037752, NA037757, NA037761,
NA037762, NA037765, NA037766, NA037768, NA037769, NA037770, NA037773, NA037775,
NA037779, NA037780, NA037781, NA037782, NA037784, NA037785, NA037786, NA037787,
NA037788, NA037789, NA037790, NA037794, NA037795, NA037796, NA037797, NA037798,
NA037800, NA037801, NA037802, NA037803, NA037804, NA037805, NA037806, NA037808,
NA037809, NA037810, NA037811, NA037814, NA037816, NA037817, NA037818, NA037819,
NA037821, NA037822, NA037823, NA037824, NA037825, NA037826, NA037828, NA037829,
NA037831, NA037832, NA037834, NA037835, NA037836, NA037837, NA037838, NA037839,
NA037840, NA037841, NA037842, NA037843, NA037844, NA037845, NA037846, NA037847,
NA037848, NA037849, NA037850, NA037851, NA037852, NA037853, NA037854, NA037855,
NA037856, NA037857, NA037858, NA037859, NA037860, NA037861, NA037862, NA037863,
NA037864, NA037866, NA037867, NA037869, NA037870, NA037871, NA037872, NA037873,
NA037874, NA037875, NA037876, NA037877, NA037878, NA037879, NA037880, NA037881,
NA037882, NA037883, NA037884, NA037885, NA037886, NA037887, NA037888, NA037889,
NA037890, NA037891, NA037892, NA037893, NA037894, NA037895, NA037896, NA037897,
NA037898, NA037899, NA037900, NA037901, NA037902, NA037903, NA037904, NA037905,
NA037906, NA037907, NA037908, NA037909, NA037911, NA037912, NA037913, NA037915,
NA037918, NA037919, NA037920, NA037922, NA037923, NA037924, NA037926, NA037927,
NA037928, NA037929, NA037930, NA037931, NA037932, NA037933, NA037934, NA037935,
NA037936, NA037937, NA037939, NA037940, NA037942, NA037943, NA037944, NA037946,
NA037947, NA037948, NA037950, NA037952, NA037954, NA037959, NA037960, NA037963,
NA037969, NA037971, NA037972, NA037973, NA037975, NA037977, NA037978, NA037979,
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NA038047, NA038048, NA038049, NA038050, NA038051, NA038052, NA038053, NA038054,
NA038056, NA038057, NA038058, NA038059, NA038060, NA038061, NA038062, NA038063,
NA038064, NA038065, NA038066, NA038067, NA038068, NA038069, NA038070, NA038072,
NA038073, NA038074, NA038075, NA038076, NA038077, NA038078, NA038080, NA038081,
NA038082, NA038083, NA038084, NA038085, NA038086, NA038087, NA038088, NA038089,
NA038090, NA038091, NA038092, NA038093, NA038094, NA038095, NA038096, NA038097,
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NA038106, NA038107, NA038108, NA038109, NA038110, NA038111, NA038112, NA038113,
NA038114, NA038116, NA038117, NA038118, NA038119, NA038120, NA038121, NA038122,
NA038123, NA038124, NA038125, NA038126, NA038127, NA038128, NA038129, NA038130,
NA038131, NA038132, NA038133, NA038134, NA038135, NA038136, NA038137, NA038138,
NA038139, NA038140, NA038141, NA038142, NA038143, NA038144, NA038145, NA038146,
NA038147, NA038148, NA038149, NA038150, NA038151, NA038152, NA038153, NA038154,
NA038155, NA038156, NA038157, NA038158, NA038159, NA038160, NA038161, NA038162,
NA038163, NA038164, NA038165, NA038166, NA038167, NA038168, NA038169, NA038170,
NA038171, NA038172, NA038174, NA038175, NA038176, NA038177, NA038178, NA038179,
NA038180, NA038181, NA038182, NA038183, NA038184, NA038185, NA038186, NA038187,
NA038188, NA038189, NA038190, NA038191, NA038193, NA038194, NA038195, NA038196,
NA038197, NA038198, NA038199, NA038200, NA038201, NA038202, NA038203, NA038204,
NA038205, NA038206, NA038207, NA038208, NA038209, NA038210, NA038211, NA038213,
NA038214, NA038215, NA038216, NA038217, NA038218, NA038219, NA038220, NA038221,
NA038222, NA038223, NA038224, NA038225, NA038226, NA038227, NA038228, NA038229,
NA038230, NA038231, NA038232, NA038233, NA038234, NA038235, NA038236, NA038237,
NA038238, NA038239, NA038240, NA038241, NA038242, NA038243, NA038244, NA038245,
NA038246, NA038247, NA038249, NA038250, NA038251, NA038252, NA038253, NA038254,
NA038255, NA038256, NA038257, NA038258, NA038259, NA038260, NA038261, NA038262,
NA038263, NA038264, NA038265, NA038266, NA038267, NA038268, NA038269, NA038270,
NA038271, NA038272, NA038273, NA038274, NA038275, NA038276, NA038277, NA038278,
NA038279, NA038280, NA038281, NA038282, NA038283, NA038284, NA038285, NA038286,
NA038287, NA038288, NA038289, NA038290, NA038291, NA038292, NA038293, NA038294,
NA038295, NA038296, NA038297, NA038298, NA038299, NA038300, NA038301, NA038302,
NA038303, NA038304, NA038305, NA038306, NA038307, NA038308, NA038309, NA038310,
NA038311, NA038312, NA038313, NA038314, NA038315, NA038316, NA038317, NA038318,
NA038319, NA038320, NA038321, NA038322, NA038323, NA038324, NA038325, NA038326,
NA038327, NA038328, NA038329, NA038330, NA038331, NA038332, NA038333, NA038334,
NA038335, NA038336, NA038337, NA038338, NA038339, NA038340, NA038341, NA038342,
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NA038351, NA038352, NA038353, NA038354, NA038355, NA038356, NA038357, NA038358,
NA038359, NA038360, NA038361, NA038362, NA038363, NA038364, NA038365, NA038366,
NA038367, NA038368, NA038369, NA038370, NA038371, NA038372, NA038373, NA038374,
NA038375, NA038376, NA038377, NA038378, NA038379, NA038380, NA038381, NA038382,
NA038383, NA038384, NA038385, NA038388, NA038389, NA038390, NA038392, NA038393,
NA038396, NA038397, NA038398, NA038399, NA038400, NA038403, NA038404, NA038406,
NA038407, NA038409, NA038410, NA038412, NA038413, NA038414, NA038415, NA038416,
NA038417, NA038420, NA038421, NA038422, NA038423, NA038425, NA038427, NA038428,
NA038429, NA038430, NA038432, NA038434, NA038435, NA038436, NA038437, NA038438,
NA038439, NA038440, NA038441, NA038442, NA038443, NA038447, NA038448, NA038449,
NA038450, NA038452, NA038453, NA038454, NA038455, NA038456, NA038457, NA038458,
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NA038476, NA038477, NA038478, NA038479, NA038483, NA038484, NA038485, NA038486,
NA038489, NA038490, NA038492, NA038493, NA038494, NA038496, NA038498, NA038499,
NA038500, NA038501, NA038502, NA038503, NA038504, NA038505, NA038506, NA038507,
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NA038574, NA038575, NA038576, NA038577, NA038578, NA038579, NA038580, NA038581,
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NA038592, NA038593, NA038594, NA038595, NA038596, NA038597, NA038598, NA038599,
NA038600, NA038601, NA038602, NA038603, NA038604, NA038605, NA038607, NA038608,
NA038609, NA038610, NA038612, NA038613, NA038614, NA038616, NA038618, NA038619,
NA038624, NA038625, NA038626, NA038627, NA038628, NA038629, NA038630, NA038632,
NA038634, NA038635, NA038636, NA038637, NA038638, NA038639, NA038640, NA038641,
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NA038675, NA038676, NA038677, NA038678, NA038679, NA038680, NA038683, NA038684,
NA038685, NA038686, NA038687, NA038688, NA038690, NA038691, NA038692, NA038693,
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NA038706, NA038707, NA038709, NA038711, NA038712, NA038713, NA038714, NA038715,
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NA038757, NA038758, NA038759, NA038760, NA038761, NA038762, NA038763, NA038764,
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NA038773, NA038774, NA038775, NA038776, NA038777, NA038778, NA038779, NA038780,
NA038781, NA038782, NA038783, NA038784, NA038785, NA038786, NA038787, NA038788,
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NA038816, NA038817, NA038818, NA038819, NA038820, NA038821, NA038822, NA038823,
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NA038841, NA038842, NA038843, NA038845, NA038846, NA038847, NA038848, NA038849,
NA038850, NA038851, NA038852, NA038853, NA038854, NA038855, NA038856, NA038857,
NA038858, NA038859, NA038860, NA038861, NA038862, NA038863, NA038864, NA038865,
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NA038875, NA038876, NA038877, NA038878, NA038879, NA038880, NA038881, NA038882,
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NA038892, NA038894, NA038896, NA038897, NA038898, NA038899, NA038900, NA038901,
NA038902, NA038903, NA038904, NA038905, NA038906, NA038907, NA038908, NA038909,
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NA038935, NA038936, NA038937, NA038938, NA038939, NA038940, NA038942, NA038943,
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NA038993, NA038994, NA038995, NA038996, NA038997, NA039004, NA039005, NA039006,
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NA039026, NA039027, NA039028, NA039029, NA039030, NA039031, NA039032, NA039033,
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NA039070, NA039071, NA039072, NA039073, NA039074, NA039075, NA039076, NA039077,
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NA039095, NA039096, NA039097, NA039098, NA039099, NA039100, NA039101, NA039102,
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NA039111, NA039112, NA039113, NA039114, NA039115, NA039116, NA039117, NA039118,
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NA039135, NA039136, NA039137, NA039138, NA039139, NA039140, NA039141, NA039142,
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NA039183, NA039184, NA039185, NA039186, NA039187, NA039188, NA039189, NA039190,
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NA039264, NA039265, NA039266, NA039267, NA039268, NA039269, NA039270, NA039271,
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NA039280, NA039281, NA039282, NA039283, NA039284, NA039285, NA039286, NA039287,
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NA039296, NA039297, NA039298, NA039299, NA039300, NA039301, NA039302, NA039303,
NA039304, NA039305, NA039306, NA039307, NA039308, NA039309, NA039310, NA039311,
NA039312, NA039313, NA039314, NA039315, NA039316, NA039317, NA039318, NA039319,
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NA039331, NA039332, NA039334, NA039335, NA039336, NA039337, NA039340, NA039341,
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NA039351, NA039352, NA039353, NA039354, NA039355, NA039356, NA039357, NA039358,
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NA039376, NA039377, NA039378, NA039379, NA039380, NA039381, NA039382, NA039383,
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NA039401, NA039402, NA039403, NA039404, NA039405, NA039406, NA039407, NA039408,
NA039409, NA039410, NA039411, NA039412, NA039413, NA039414, NA039415, NA039416,
NA039417, NA039418, NA039419, NA039420, NA039421, NA039422, NA039423, NA039424,
NA039425, NA039426, NA039427, NA039428, NA039429, NA039430, NA039431, NA039432,
NA039433, NA039434, NA039435, NA039436, NA039437, NA039438, NA039439, NA039440,
NA039441, NA039442, NA039443, NA039444, NA039445, NA039446, NA039447, NA039448,
NA039449, NA039450, NA039451, NA039452, NA039453, NA039454, NA039455, NA039456,
NA039457, NA039458, NA039459, NA039460, NA039461, NA039462, NA039463, NA039464,
NA039465, NA039466, NA039467, NA039468, NA039469, NA039470, NA039471, NA039472,
NA039473, NA039474, NA039475, NA039476, NA039477, NA039478, NA039479, NA039480,
NA039481, NA039482, NA039483, NA039484, NA039485, NA039486, NA039487, NA039488,
NA039489, NA039490, NA039491, NA039492, NA039493, NA039494, NA039495, NA039497,
NA039498, NA039499, NA039500, NA039501, NA039502, NA039503, NA039504, NA039505,
NA039506, NA039507, NA039508, NA039510, NA039511, NA039512, NA039514, NA039515,
NA039516, NA039517, NA039518, NA039519, NA039520, NA039521, NA039522, NA039523,
NA039524, NA039525, NA039526, NA039527, NA039528, NA039529, NA039530, NA039531,
NA039532, NA039533, NA039534, NA039535, NA039536, NA039537, NA039538, NA039539,
NA039540, NA039541, NA039542, NA039543, NA039544, NA039545, NA039546, NA039547,
NA039548, NA039549, NA039550, NA039551, NA039552, NA039553, NA039554, NA039555,
NA039556, NA039558, NA039560, NA039561, NA039562, NA039563, NA039564, NA039565,
NA039566, NA039567, NA039568, NA039569, NA039570, NA039571, NA039572, NA039573,
NA039574, NA039575, NA039577, NA039578, NA039579, NA039581, NA039582, NA039584,
NA039585, NA039586, NA039588, NA039589, NA039591, NA039592, NA039593, NA039595,
NA039598, NA039599, NA039600, NA039601, NA039603, NA039604, NA039605, NA039607,
NA039608, NA039609, NA039612, NA039616, NA039618, NA039619, NA039620, NA039621,
NA039623, NA039624, NA039629, NA039630, NA039632, NA039633, NA039639, NA039644,
NA039645, NA039650, NA039655, NA039664, NA039674, NA039692, NA039701, NA039702,
NA039703, NA039711, NA039715, NA039719, NA039720, NA039722, NA039723, NA039724,
NA039726, NA039728, NA039729, NA039730, NA039732, NA039733, NA039734, NA039735,
NA039736, NA039737, NA039741, NA039742, NA039743, NA039744, NA039747, NA039748,
NA039750, NA039751, NA039753, NA039754, NA039755, NA039756, NA039757, NA039758,
NA039759, NA039760, NA039761, NA039762, NA039763, NA039764, NA039766, NA039767,
NA039771, NA039772, NA039773, NA039774, NA039776, NA039778, NA039780, NA039781,
NA039782, NA039784, NA039785, NA039786, NA039787, NA039790, NA039793, NA039795,
NA039796, NA039797, NA039798, NA039799, NA039800, NA039802, NA039803, NA039804,
NA039805, NA039806, NA039808, NA039809, NA039810, NA039814, NA039828, NA039839,
NA039842, NA039843, NA039844, NA039846, NA039847, NA039848, NA039849, NA039850,
NA039851, NA039852, NA039853, NA039854, NA039855, NA039856, NA039857, NA039858,
NA039859, NA039860, NA039865, NA039866, NA039868, NA039871, NA039876, NA039877,
NA039878
RECALLING FIRM/MANUFACTURER Welch Allyn
Protocol, Inc, Beaverton, OR
REASON Failure to Deliver Shock; a defective
capacitor may cause the delay or non-delivery of the defibrillating shock which
may result in failure to resuscitate the patient.
VOLUME OF PRODUCT
IN COMMERCE 1,795
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Abbott
Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20),
For In Vitro Diagnostic use. This reagent system is composed of one bottle of
Digoxin-Alkaline Phosphates Conjugate, one bottle of Anti-Digoxin (Rabbit)
Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin
Probe wash solution.,
CODE Lot #
46181Q100 Exp. Date 08/10/07, Lot # 50267Q100 Exp.Date
12/16/07
RECALLING FIRM/MANUFACTURER Abbott Diagnostic
International, Ltd., Barceloneta, PR,
REASON Incorrect Results --
Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on
the AxSYM Digoxin III assay, rather than a concentration, is reported for the
patient sample.
VOLUME OF PRODUCT IN COMMERCE 3,104
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Sunisa
Flexi-DT S0014115 Digital Table Flexi-DT, 115-240 V // Internal Battery 24V,
4-2A Internal Battery 8A, 50-60Hz. Model Numbers 51335678, 2269647, 2242088-2,
5141609-2, 5115763, and 5128145,
CODE
Model # 2269647 / Serial #
00001001025WK4 00001001930WK5 00001002256WK4 00001002566WK6 00001002571WK6
00001003965WK9 00001004156WK4 00001004469WK1 00001007157WK9 Model # 5115763 /
Serial# 00000994502WK3 00000997066WK6 00000997612WK7 00000997613WK5
00001000007WK3 00001002479WK2 00001002828WK0 00001003563WK2 00001003571WK5 Model
#5128145 / Serial # 00000002041M32 00000002051M31 00001004319WK8 00001005661WK2
Model#5135678 / Serial # 00001004505WK2 00001004507WK8 00001004763WK7
00001004764WK5 00001004771WK0 00001005019WK3 00001005032WK6 00001005033WK4
00001005182WK9 00001005184WK5 00001005260WK3 00001005702WK4 00001005705WK7
00001005707WK3 00001005755WK2 00001005760WK2 00001005762WK8 00001005763WK6
00001005764WK4 00001005911WK1 00001005912WK9 00001006042WK4 00001006179WK4
00001006471WK5 00001006475WK6 00001006478WK0 00001006635WK5 00001006822WK9
00001006873WK2 00001006875WK7 00001006878WK1 00001006880WK7 00001007163WK7
00001007169WK4 00001007191WK8 00001007405WK2 00001007409WK4 00001007478WK9
00001007499WK5 00001007516WK6 00001007528WK1 00001007534WK9 00001007535WK6
00001007649WK5 00001007650WK3 00001007713WK9 00001007717WK0 00001007719WK6
00001007780WK8 00001007782WK4 00001007784WK0 00001007906WK9 00001007910WK1
00001008307WK9 00001008312WK9 00001008682WK5 00001008809WK4 00001008810WK2
00001008835WK9 00001008837WK5 00001008843WK3 00001009057WK9 00001009061WK1
00001009062WK9 00001009063WK7 00001009217WK9 00001009536WK2 00001009604WK8
00001009609WK7 00001009707WK9 00001009817WK6 00001010430WK5 Model #2242088-2 /
Serial # 00000001709M35 Model #5141608-2 / Serial # 00000114134VE0
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE
Healthcare, LLC, Waukesha, WI,
Manufacturer: Suinsa, Madrid, Spain.
REASON Suinsa Flex-DT Table - Reports of several
problems including: 1) Hot Brake (Longitudinal Overheating) potential risk of
burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open
instead of closed 4) Longitudinal Brakes Release does not engage properly 5)
Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to
patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potential
risk of falling to patient and/or operator.
VOLUME OF PRODUCT IN
COMMERCE 96 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Foundation® Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040;
Sterile; assembly required by physician prior to implant;
b) Foundation® Hip System Bipolar Modular, Size 41mm
OD; Cat. #412-01-041;
Sterile; assembly required by
physician prior to implant;
c) Foundation® Hip System
Bipolar Modular, Size 42mm OD; Cat. #412-01-042;
Sterile;
assembly required by physician prior to implant;
d)
Foundation® Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043;
Sterile; assembly required by physician prior to
implant;
e) Foundation® Hip System Bipolar Modular,
Size 44mm OD; Cat. #412-01-044;
Sterile; assembly
required by physician prior to implant;
f) Foundation®
Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045;
Sterile; assembly required by physician prior to implant;
g) Foundation® Hip System Bipolar Modular, Size 46mm
OD; Cat. #412-01-046;
Sterile; assembly required by
physician prior to implant;
h) Foundation® Hip System
Bipolar Modular, Size 47mm OD; Cat. #412-01-047;
Sterile;
assembly required by physician prior to implant;
i) Foundation® Hip System Bipolar Modular, Size 48mm OD;
Cat. #412-01-048;
Sterile; assembly required by physician
prior to implant;
j) Foundation® Hip System Bipolar
Modular, Size 49mm OD; Cat. #412-01-049;
Sterile;
assembly required by physician prior to implant;
k)
Foundation® Hip System Bipolar Modular, Size 50mm OD; Cat.
#412-01-050;
Sterile; assembly required by physician prior
to implant;
l) Foundation® Hip System Bipolar Modular,
Size 51mm OD; Cat. #412-01-051;
Sterile; assembly
required by physician prior to implant;
m) Foundation®
Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052;
sterile; assembly required by physician
prior to implant;
n) Foundation® Hip System
Bipolar Modular, Size 53mm OD; Cat. #412-01-053;
Sterile;
assembly required by physician prior to implant;
o)
Foundation® Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054;
Sterile; assembly required by physician prior to implant;
p) Foundation® Hip System Bipolar Modular, Size 56mm
OD; Cat. #412-01-056;
Sterile; assembly required by
physician prior to implant;
q) Foundation® Hip System
Bipolar Modular, Size 58mm OD; Cat. #412-01-058;
Sterile;
assembly required by physician prior to implant;
r)
Foundation® Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060;
Sterile; assembly required by physician prior to implant;
CODE
a) Lot #: 633811, 633851,
738381, 738391, 770021, 777371, 792441, 817581,
831031, 878311, 905531, 905541, 907051, 944231, and
949371;
b) Lot #: 602661, 691241, 633821, 633861, 738401, 770031, 777381,
792451,
797031, 811141, 831041, 836151, 845221, 848651,
857671, 878321, 905551,
932691, 949381, 958921 and
964161;
c) Lot #: 644021, 648331, 672341, 675901, 678461, 678471, 678481,
678491, 678501,
678511, 678521, 693251, 694501, 697771,
732831, 733871, 736411, 736741,
738071, 738081, 738411,
738421, 770041, 774781, 774791, 777391, 779571,
779581,
783901, 783911, 788351, 794371, 794381, 811151, 811161, 835501,
835511, 836161, 844591, 845951, 848661, 854461, 854471,
854481, 854491,
857681, 874941, 874951, 882561, 882571,
882581, 893551, 893561, 893571,
903121, 903131, 933751,
944241, 944251, 949391, 949401, 964171, 964181,
964191
and 964201;
d) Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661,
692771, 692761,
694351, 694401, 694411, 694421, 698261,
695131, 695911, 697781, 730131,
731451, 731461, 731471,
205452, 736421, 770051, 770061, 770071, 770181,
780151,
783921, 788361, 792671, 794391, 811171, 811181, 811191,
811201,
811291, 832281, 832291, 835521, 842301, 842311,
848671, 854501, 854511
54981, 874961, 874971, 874981,
882591, 882601, 893581, 893591, 893601,
893611, 903141,
903151, 905561, 925731, 925741, 925751, 927231, 932711,
932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421,
964211,
964221, 964231 and 964241;
e) Lot #:
640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611,
678621, 679611, 679621, 693841, 693851, 693861, 695121,
695861, 697851,
697861, 698771, 730141, 730221, 731481,
003612, 003622, 003632, 003642,
208672, 735781, 736431,
736441, 736451, 736461, 736751, 737391, 738431,
738891,
738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931,
788381, 788391, 794401, 795481, 795491, 812181, 812191,
812201, 812211,
813511, 817551, 817561, 833181, 833191,
834981, 834991, 837691, 837791,
842321, 842331, 847351,
847361, 847391, 847401, 854341, 854381, 854391,
854401,
854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531,
878541, 882611, 882621, 882631, 891271, 891281, 891301,
893631, 893641,
905571, 905581, 907081, 907091, 907101,
907111, 925761, 925771, 932731,
932741, 938211, 938221,
949431, 949441, 951081, 964251, 964261, 964271,
964281,
964291, 964301, 964311 and 421494A;
f) Lot #: 629071, 677121, 677131, 678651,
678661, 678671, 678681, 679641,
691251, 691261, 691271,
693871, 693881, 694511, 694521, 694531, 695111,
697791,
698971, 698981, 730201, 731491, 733951, 734531, 736471,
736481,
736761, 738091, 738101, 738901, 770091, 772351,
772361, 777411, 780171,
783941, 788411, 788421, 795501,
795511, 812221, 813521, 813531, 814301,
814311, 817571,
834021, 834031, 835551, 836171, 842341, 842351, 845961,
847381, 854351, 854421, 854431, 854441, 855871, 855881, 857721, 875011,
875021, 878341, 878361, 878551, 878561, 891291, 891311,
893621, 894391,
894401, 905591, 905601, 907061, 907071,
925781, 925791, 932751, 938231,
938241, 938251, 949451,
949461, 951091, 959761, 959771, 964321, 964331,
964341
and 964351;
g) Lot #: 644031, 672331, 677061, 677981, 677991, 678691, 678701,
678711,
678721, 679651, 679661, 697671, 691281, 691291,
693261, 699171, 730241,
735791, 736491, 736501, 736511,
736771, 737811, 738441, 738451, 738461,
770101, 770111,
770221, 773281, 777421, 778431, 782551, 788441, 788451,
810911, 811211, 813501, 830751, 830761, 830911, 830921, 835531, 835541,
842361, 842371, 847411, 848681, 848691, 853541, 857731,
857741, 857751,
875571, 875581, 878371, 878381, 878391,
885381, 885401, 892331, 894241,
894251, 905611, 907121,
907131, 907141, 907211, 925801, 925811, 927241,
927251,
927261, 932761, 949471, 949491, 949851, 951101, 951111, 951121,
958941, 966131, 966141 and 982721;
h) Lot #: 602731,
677071, 677081, 677091, 678001, 678011, 678731, 678741,
678751, 678761, 693891, 693901, 695101, 697801, 699141, 699151, 732841,
208522, 208532, 208542, 208552, 733961, 734521, 735721,
736521, 739121,
770121, 777431, 780391, 783951, 788491,
796481, 797041, 797341, 814321,
814331, 830931, 830941,
835561, 836181, 842381, 844601, 848701, 853551,
855191,
855201, 857761, 857771, 875591, 875601, 878401, 878411,
878421,
878431, 885391, 892341, 907151, 907161, 907171,
907181, 907191, 907201,
925821, 933801, 933811, 933821,
933831, 949501, 949511, 964361, 964371,
982731 and
421511A;
i) Lot #: 546541, 675911, 677601, 678771, 678781, 693911, 693921,
695081,
697091, 697811, 699931, 730251, 732541, 732851,
735731, 736531, 736781,
739441, 770131, 777441, 777451,
781061, 783961, 788501, 788511, 794411,
794421, 797051,
830291, 830301, 830951, 835571, 835581, 842391, 842401,
844611, 854991, 857781, 872031, 872041, 872051, 872061, 878571, 878581,
885411, 885421, 892351, 892361, 892371, 892381, 905621,
905881, 907221,
933841, 933851, 933861, 938261, 939751,
944281, 944291, 964381, 964391,
964401, 982741 and
421521A;
j) Lot #: 624391, 675921, 678791, 678801, 678811, 678821, 679691,
691671,
693931, 693941, 695061, 695921, 696971, 697101,
699941, 208562, 208582,
732861, 733821, 733841, 734401,
735741, 736541, 770141, 773291, 773301,
777461, 779901,
783971, 788521, 794431, 797061, 830311, 831511, 835591,
835601, 842411, 842421, 857791, 872071, 882641, 892391, 892401,
905891,
905901, 907231, 933871, 938271, 958951, 964411,
964421 and 421531A;
k) Lot #: 624401, 676821, 677141, 677611, 678831, 678841,
678851, 678861,
678871, 695171, 633831, 733831, 734561,
738471, 738481, 738491, 770151,
777471, 778441, 778451,
788531, 788541, 814371, 830961, 840341, 840351,
840361,
844621, 854641, 854651, 855001, 857801, 894261, 894271, 905631,
905641, 905651, 907241, 933881, 933891, 949521, 949531,
958961, 964431,
964441 and 964451;
l) Lot #: 542491,
624411, 676831, 678881, 678891, 679701, 690791, 695161,
695931, 735751, 770161, 777481, 777491, 788551, 794441, 814361, 830971,
844631, 844641, 847421, 850801, 854661, 854671, 875521,
875531, 878441,
882651, 882661, 894281, 894291, 905661,
907251, 933901, 949551 and 964471;
m) Lot #: 624421, 676851, 676861, 677151,
678901, 678911, 678921, 693271,
695151, 738501, 739461,
770171, 777501, 777511, 781071, 788561, 794451,
814351,
830981, 830991, 855011, 875541, 878451, 894301, 894311, 894321,
907261, 933911, 949561 and 949571;
n) Lot #: 676841, 678931, 678941,
679711, 690801, 695141, 695941, 777521,
781081, 788571,
814341, 831001, 844641, 854681, 855021, 878591, 894331,
894341, 894351, 907271, 933921, 933931, 949581, 949591, 964481, 964491
and 519861A;
o) Lot #: 608031, 648321, 675931, 678951,
678961, 678971, 695091, 695851,
780401, 788581, 788591,
788601, 794461, 831021, 840371, 844651, 848711,
855031, 857811, 875551, 894361, 894371, 907281, 933941, 949601, 964501
and 964511;
p) Lot #: 627751, 629111, 678981, 678991,
679001, 690231, 210192, 695841,
855041, 875561, 882671,
894381, 905671, 9072291, 939741, 949611 and 964521;
q) Lot #: 546711, 546721,
546731, 679011, 679021, 379031, 679041, 679051,
695071,
695871 and 989981;
r) Lot #: 677621, 679061, 679071, 679081, 679091, 633841,
695881, 899041 and
989991
RECALLING
FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON
Device mislabeled. Hip prosthesis
components validated for 5 years were labeled as having a 6 year expiration
date.
VOLUME OF PRODUCT IN COMMERCE 5,191
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Portex
perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090,
CODE
Lot:
1155185
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Smiths Medical ASD, Inc., Keene, NH,
Manufacturer: Smiths Medical, Kent, UK.
REASON
Mislabeled. The product is labeled as a
size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy
tube.
VOLUME OF PRODUCT IN COMMERCE 40
units
DISTRIBUTION Nationwide
PRODUCT GE
Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1
and DICOM stations with these software versions; CODE
Serial Numbers: D00210, D00223, D00225,
D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455,
D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484,
D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512,
D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542,
D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561,
D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571,
D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582,
D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649,
D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139,
D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192,
D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220,
D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242,
D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292,
D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306,
D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330,
D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350,
D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366,
D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396,
D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413,
D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387,
D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513,
D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556,
D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255,
D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301,
D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593,
D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217,
D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504,
D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635,
D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279,
D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394,
D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245,
D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431,
D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234,
D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205,
D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458,
D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594,
D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204,
D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276,
D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309,
D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401,
D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162,
D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283,
D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450,
D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535,
D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610,
D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623,
D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651,
D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101,
D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158,
D00163, D00175, D00188, D00278, D00294, D00333, D00357, D00373, D00376, D00381,
D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417,
D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501. Version 6.2.0
was distributed 3/24/07 and version 6.2.1: 4/10/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa, WI,
Manufacturer: GE Medical Systems, Kretztechnik GmbH
& Co. OHG, Zipf, Austria.
REASON When a spectrum of a Pulsed Wave Doppler
shows an angle correction unequal to 0 is reloaded from the archive or the image
is sent to a DICOM station, this angle correction is mistakenly disregarded
resulting in an underestimation of the flow velocities.
VOLUME OF
PRODUCT IN COMMERCE 521
units
DISTRIBUTION Nationwide
PRODUCT Medtronic
Sofamor Danek METRx ™ System Bayonet Electrosurgical Pencil, sterile; REF (P/N)
9560575;
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warsaw
Orthopedic, Inc. dba Medtronic Sofamor Danek, Warsaw, IN,
Manufacturer: Zinnanti Surgical Design
LLC, Hershey, PA.
REASON Packaging
weakness may compromise sterility and instructions for use are
inadequate.
VOLUME OF PRODUCT IN COMMERCE Approximately
22,632 pencils
DISTRIBUTION Nationwide and
Internationally
PRODUCT The
Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The
malfunctioning software application is the Tumor Localization (Tumor LOC)
application.
All Brilliance CT Big Bore Scanners with Tumor Localization
software versions v2.2.1, v2.2.2, & v2.2.5. This software version is
included on Brilliance CT Big Bore Scanners, Model Number 728243;
CODE
Serial Numbers 7001 -
7215
RECALLING FIRM/MANUFACTURER Philips Medical Systems
(Cleveland) Inc., Cleveland, OH
REASON The maximum intensity
projection (MIP) images produced from respiratory gated images by the Tumor
Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners
will be labeled incorrectly for certain patient orientations and view
conventions when saved for later viewing.
VOLUME OF PRODUCT IN
COMMERCE 206 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Storz
Equipment, Fluid Management Stand, for Fluid Management Systems, Product number:
26601EQ-KT,
CODE Product has
no lot or serial numbers.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Karl Storz Endoscopy America,
Inc., Culver City, CA,
Manufacturer: Mpe,
Inc., Milwaukee, WI.
REASON Outflow Difference. The accuracy of the
equipment displayed value could be influenced by external factors of the
cart/stand and may result in a fluctuating or inaccurate
reading.
VOLUME OF PRODUCT IN COMMERCE 287
units
DISTRIBUTION Nationwide
PRODUCT
a)
Mevatron KD2,Medical charge-particle radiation therapy system (Medical Digital
Linear Accelerator), Model Number: 1940753;
b) Mevatron KD-2,Medical charge-particle radiation therapy
system (Medical Digital
Linear Accelerator), Model
Numbers: 8515520 and 9822685;
c) Mevatron KDS,Medical
charge-particle radiation therapy system (Medical Digital
Linear Accelerator), Model Number: 9401522;
d) Mevatron KDS-2,Medical charge-particle radiation
therapy system (Medical
Digital Linear Accelerator),
Model Numbers: 9411588 and 9822693;
e) Mevatron-2 6300, Medical charge-particle radiation therapy system
(Medical Digital
Linear Accelerator), Model Number:
9401316;
f) Mevatron M-2 6700,Medical
charge-particle radiation therapy system (Medical
Digital
Linear Accelerator), Model Number: 9401407;
g) Mevatron
M-2 6740, Medical charge-particle radiation therapy system (Medical
Digital Linear Accelerator), Model Number: 9401506;
h) Mevatron MD-2, Medical charge-particle radiation
therapy system (Medical
Digital Linear Accelerator),
Model Number: 9401654;
i) Mevatron MDX-2, Medical
charge-particle radiation therapy system (Medical
Digital
Linear Accelerator), Model Number: 9401746;
j) Oncor
Avant Garde, Medical charge-particle radiation therapy system (Medical
Digital Linear Accelerator), Model Number: 5863472;
k) Oncor Expression,Medical charge-particle radiation
therapy system (Medical
Digital Linear Accelerator),
Model Numbers: 7360204 and 7360717;
l) Oncor Impression Plus,Medical charge-particle radiation
therapy system (Medical
Digital Linear Accelerator),Model
Number: 5857912;
m) Oncor Impression, Medical
charge-particle radiation therapy system (Medical
Digital Linear Accelerator), Model Number: 5857920;
n)
Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system
(Medical Digital Linear Accelerator), Model Number
1940035,;
o) Primus Plus,
Medical charge-particle radiation therapy system (Medical Digital
Linear Accelerator), Model Number: 4504200;
CODE
a) Serial numbers 2509, 2568, 2698,
2168, 2459, 2589, 2616, 2667, 1985, 2145,
2213, 2216,
2218, 2297, 2571, 2582, 2602, 2612, 2636, 2776, 2038, 2448, 2451,
2452, 2466, 2505, 2525, 2531, 2547, 2567, 2575, 2578,
2681, 2686, 2751, 2769,
2777, 2781, 2229, 2726, 2111,
2245, 2561, 1798, 2414, 2542, 2585, 2607, 2631,
2724,
2731, 2739, 2824, 2826, 2858, 2859, 2864, 2877, 2951, 2952, 3021, 3029,
3035, 3041, 2394, 2648, 2663, 2801, 2729, 2587, 2592,
02574A, 2498, 2621,
2704, 2494, 2601, 2807, 2327, 2405,
2569, 2353, 2754;
b) Serial Numbers: 1633, 1772, 1874, 1901, 1938, 1941,
1944, 1987, 2014, 2076,
2082, 2088, 2135, 2154, 2173,
2175, 2179, 2228, 2246, 2273, 2315, 2329, 2348,
2383,
2508, 2562, 2568, 2579, 2586, 2598, 2614, 2634, 2645, 2646, 2656, 2676,
2679, 2713, 2743, 2756, 2202, 2462, 2436, 2472, 2474,
2652, 2133, 2224, 2319,
2099, 4, 5, 1894, 1928, 1948,
2043, 2074, 2128, 2131, 2376, 2431, 2437, 2441,
2444,
2496, 2584, 2595, 2687, 2711, 2721, 2757, 2774, 2558, 2726, 2111, 2115,
2457, 2714, 2065, 2413, 2414, 2542, 2577, 2585, 2606,
2623, 2631, 2724, 2725,
2727, 2732, 2739, 2775, 2786,
2824, 2826, 2858, 2859, 2864, 2481, 2563, 2609,
2617,
2638, 2639, 2643, 2649, 2659, 2672, 2697, 2734, 2742, 2771, 2811, 2837,
2885, 2561, 2715, 2718, 02587A, 02592A, 2498, 2621, 2537,
2601, 2422, 2483,
2541, 2624, 2123, 2282, 2327, 2405,
2405, 1953, 2662, 2479, 2569, 2127, 2345,
2754;
c) Serial Numbers: 1917, 1988, 2019, 2232, 2104, 2069, 2193, 2194,
2221, 2159;
d) Serial Numbers: 2055, 2097, 2106, 2108, 2122, 2183, 2208,
2222, 2242, 2244, 2251, 2263, 2269, 2272, 2276, 2284, 2289, 2324, 2335, 2336,
2339, 2357, 2358, 2372, 2513, 2514, 2518, 2665, 2691, 2108A, 2023, 2158, 2168,
2398, 2398BIS, 2264, 2084, 2447, 2453, 2553, AB4220323T, 2229, 2111, 2485, 2402,
2394, 2115, 2245, 2304, 2519, 2327, 2196, 2353;
e) Serial Numbers: 2489,
2594, 2635, 2703, 2407, 24581968;
f) Serial Numbers: 1966, 2029, 2223,
2488, 2787, 2408, 2651, 2752, 2239, 2429, 2861, 2849, 2219, 2432, 2464, 2664,
2418, 2428, 2708, 2779, 2619, 2704, 2802, 2749;
g) Serial
Numbers: 2011, 2093, 2156, 2161, 2171, 2177, 2186, 2211, 2227, 2247, 2254, 2271,
2325, 2338, 2343, 2349, 2355, 2367, 2369, 2523, 2526, 2758, 2767, 2435, 2591,
2164, 2267, 1969, 2484, 2389, 2301, 2417, 2442, 2581, 2608, 2629, 2632, 2633,
2693, 2741, 2821, 2331, 2723, 2456, 2468, 2533, 2766, 2841, 2889, 2907, 2939,
2943, 2654, 2684, 2503;
h) Serial Numbers: 1949, 1991, 1996, 2045,
2053, 2067, 2113, 2117, 2139, 2152, 2189, 2192, 2199, 2231, 2233, 2234, 2235,
2238, 2241, 2252, 2261, 2281, 2316, 2328, 2374, 2397, M2166, 2283, 2305, 2346,
2427, 2487, 2605, 2674, 2682, 2683, 2856, 2539, 2445, 2588, 2661, 2812, 2937,
2163, 2478, 2205, 2884, 2362, 2392, 2425, 2426, 2454, 2502, 2535, 2546, 2599,
2615, 2637, 2657, 2685, 2691, 2461, 2262, 2423, 2528, 2641, 2694, 2716, 2761,
2813, 2819, 2825, 2874, 2714, 2217, 2249, 2544, 2118, 2439,
2709;
i) Serial Numbers: 2125, 2137, 2538,
2499.
j) Serial Numbers: 3738, 3817, 3904,
3905, 3926, 3934, 3938, 3987, 3988,
4016, 4079, 4082, 4095, 70-4077, 70-4113,
70-4188, 70-4197, 70-4283, 70-4368, 3852,
70-4168, 70-4169, 3737, 3739, 3758, 3806,
3856, 3884, 3891, 3912, 3929, 3937,
3941, 3944, 70-4163, 70-4291, 70-4325, 3895,
3896, 4049, 70-4201, 70-4297, 70-4314,
70-4184, 70-4213, 70-4223, 5012, 70-4311,
3881, 70-4324, 70-4217, 3932;
k) Serial Numbers: 5029,
5037, 5042, 5094;
l) Serial Numbers: 3753, 3754, 3755, 3761, 3764,
3769, 3778, 3783, 3791, 3793, 3801, 3802, 3803, 3804, 3815, 3846, 3855, 3877,
3888, 3901, 3907, 3945, 3948, 3953, 3955, 3957, 3964, 3975, 3981, 3989, 3998,
4015, 4019, 4035, 4065, 4067, 4072, 4091, 5033, 5060, 5088, 5093, 5096, 70-4119,
70-4122, 70-4129, 70-4135, 70-4142, 70-4144, 70-4145, 70-4157, 70-4159, 70-4161,
70-4166, 70-4172, 70-4174, 70-4175, 70-4177, 70-4183, 70-4222, 70-4262, 70-4306,
70-4317, 70-4343, 70-4345, 70-4349, 70-4354, 70-4356, 70-4362, 70-4378, 70-4379,
3956, 4011, 70-4136, 70-4154, 70-4334, 4024, 3796, 3799, 3865, 70-4361, 3795,
4074, 5002, 5034, 5057, 3739, 3808, 4017, 4022, 4068, 4081, 4084, 4096, 5001,
5011, 5032, 5053, 5058, 5086, 5087, 5095, 70-4107, 70-4132, 70-4147, 70-4149,
70-4153, 70-4171, 70-4189, 70-4288, 70-4312, 70-4331, 70-4333, 70-4366, 5031,
70-4158, 3983, 3823, 3965, 5061, 5091, 70-4124, 70-4137, 70-4329, 70-4348, 5068,
5085, 70-4215, 70-4253, 70-4272, 70-4305, 70-4335, 70-4338, 70-4123, 70-4176,
70-4209, 3816, 4012, 4053, 5023, 70-4186, 70-4241, 70-4244, 3776, 3848, 3858,
3963, 4002, 4027, 70-4097, 70-4346, 70-4384, 4071, 3836, 3827, 4005, 5039, 5040,
70-4231, 5030, 70-4328, 70-4365, 4026, 70-4258, 70-4301, 4009, 3916, 70-4278,
3925, 3954, 5027, 5044, 5069, 70-4224, 70-4295, 70-4299, 5004, 704093, 3968,
4037, 70-4193, 70-4292, 70-4127, 3841, 3863, 4008, 4062,
4064;
m) Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207,
70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035,
5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024,
704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883,
70-4083;
n) Serial Numbers: 1966, 2011, 2029,
2046, 2156, 2171, 2177, 2186, 2247,
2261, 2506, 2507, 2512, 2515, 2516,
2517, 2521, 2522, 2524, 2526, 2527,
2532, 2572, 2573, 2593, 2596, 2611,
2613, 2622, 2626, 2644, 2647, 2669,
2678, 2689, 2692, 2695, 2696, 2699,
2702, 2705, 2722, 2735, 2738, 2745,
2758, 2765, 2767, 2784, 2791, 2792,
2794, 2806, 2814, 2816, 2817, 2818,
2834, 2845, 2847, 2855, 2857, 2875,
2898, 2901, 2906, 2913, 2921, 2929,
2955, 2959, 2961, 2962, 2965, 2968,
2974, 2988, 2995, 3009, 3013, 3016,
3018, 3045, 3055, 3057, 3061, 3071,
3078, 3082, 3084, 3089, 3101, 3103,
3116, 3118, 3126, 3133, 3136, 3138,
3147, 3156, 3162, 3192, 3207, 3208,
3228, 3232, 3243, 3258, 3274, 3285,
3287, 3294, 3296, 3298, 3303, 3304,
3316, 3353, 3364, 3383, 3397, 3409,
3425, 3433, 3434, 3435, 3439, 3448,
3458, 3482, 3495, 3503, 3512, 3517,
3541, 3557, 3576, 3591, 3604, 3605,
3616, 3617, 3618, 3623, 3624, 3629,
3631, 3639, 3644, 3664, 3673, 3678,
3692, 3699, 3702, 3736, 3748, 3756,
3774, 3788, 3798, 3805, 3826, 3842,
3859, 3873, 3931, 3939, 3986, 4018,
5092, 5500371, 70-4146, 70-4178,
70-4287, 70-4316, 70-4323,
70-4347, 70-4363, M2855, 3647, 4031, 59130,
3175, 3204, 3205, 3206, 3012, 3246,
3251, 3491, 3648, 2435, 70-4134, 2998,
3108, 3313, 2747, 2752, 2809, 2879,
2946, 3054, 3221, 3229, 3554, 3559,
3581, 3585, 3588, 3589, 3655, 3787,
3857, 3889, 3903, 3906, 3911, 3913,
3927, 5065, 70-4118, 70-4203, 70-4246, 2469,
2473, 2475, 2476, 2559, 2618, 3235,
3236, 3376, 4063, 70-4111, 2744, 3065,
3152, 3337, 2803, 2804, 2915, 3393,
3683, 4182, 4233, 1940035, 70-4182, 2861,
2603, 2969, 3301, 3575, 3625, 3627,
3676, 3882, 70-4202, 2086, 2257, 2295, 2352,
2401, 2438, 2576, 2604, 2707, 2759,
2778, 2835, 3051, 3063, 3169, 3321,
3394, 3914, 3923, 4092, 5048, 70-4284,
2005, 2057, 2443, 2465, 2543, 2545,
2552, 2597, 2625, 2642, 2653, 2673,
2675, 2688, 2706, 2719, 2737, 2748,
2795, 2822, 2831, 2876, 2881, 2926,
2932, 2935, 2947, 2953, 2971, 2984,
3001, 3015, 3056, 3059, 3062, 3086,
3088, 3096, 3099, 3141, 3197, 3253,
3314, 3328, 3363, 3415, 3652, 3792,
3885, 2949, 3358, 3385, 2868, 3449,
3451, 2566, 3712, 3847, 3946, 3951,
5016, 5025, 5082, 70-4269, 70-4319, 70-4339,
70-4369, 3609, 3789, 4248, 70-4248, 2698,
3775, 3777, 3779, 3784, 3807, 2583,
2677, 2799, 2852, 2981, 3281, 3355,
3432, 3478, 3537, 3538, 3555, 3593,
3633, 3643, 3705, 3726, 3733, 3743,
3785, 3869, 3898, 3928, 70-4151, 70-4273,
ZTVL00009, ZTVX00003, 2299, 2362, 2392,
2402, 2425, 2426, 2454, 2455, 2471,
2495, 2497, 2529, 2535, 2546, 2599,
2637, 2657, 2685, 2691, 2712, 2728,
2736, 2772, 2843, 2853, 2873, 2925,
2999, 3035, 3038, 3073, 3083, 3166,
3167, 3178, 3185, 3195, 3196, 3198,
3252, 3275, 3282, 3325, 3335, 3338,
3341, 3344, 3357, 3379, 3429, 3442,
3472, 3476, 3508, 3523, 3527, 3528,
3532, 3535, 3548, 3563, 3637, 3674,
3685, 3694, 3723, 3741, 3747, 3821,
3838, 3854, 3871, 3874, 3875, 3886,
3892, 3933, 3971, 3982, 4007, 4014,
4023, 4025, 4038, 4073, 5009, 5018,
5019, 5051, 5054, 5055, 5070, 70-4104,
70-4106, 70-4108, 70-4114, 70-4115, 70-4138,
70-4191, 70-4261, 70-4375, 70-5005, 2255,
3834, 2886, 3194, 3052, 2534, 2789,
2982, 2983, 3368, 3388, 3463, 4087,
3006, 3132, 3139, 3164, 3173, 3188,
3263, 3266, 3277, 3293, 3306, 3331,
3352, 3404, 3419, 3437, 3446, 3447, 3473,
3505, 3509, 3546, 3596, 3607, 3613,
3615, 3635, 3656, 3658, 3665, 3671,
3681, 3687, 3697, 3715, 3716, 3771,
3809, 3843, 3849, 3851, 3864, 3866,
3879, 3908, 3918, 3921, 3935, 3966,
3992, 3997, 4003, 4034, 4041, 4044,
4046, 4052, 4058, 4066, 4069, 4094,
4236, 5071, 5072, 5078, 5080, 6100,
704088, 704098, 70-4121, 70-4128, 70-4155,
70-4164, 70-4196, 70-4199, 70-4211, 70-4214,
70-4216, 70-4228, 70-4242, 70-4243, 70-4245,
70-4259, 70-4263, 70-4265, 70-4274, 70-4286,
70-4293, 70-4294, 70-4298, 70-4303, 70-4307,
70-4321, 70-4332, 70-4337, 70-4342, 70-4352,
70-4353, 70-4355, 70-4358, 70-4371, 70-4372,
70-4377, 70-4381, 70-4382, 70-4383, 70-4385,
3309, 3682, 340563, 722348, 70-4268, 3381,
2382, 3812, 2549, 2554, 2717, 2888,
70-4229, 3659, 70-4289, 2499, 2619, 2684,
2704, 2802, 3247;
o) Serial Numbers: 2701,
2733, 2762, 2768, 2823, 2827, 2828,
2836, 2839, 2842, 2846, 2848, 2863,
2867, 2887, 2893, 2894, 2896, 2899,
2911, 2912, 2914, 2931, 2933, 2934,
2936, 2941, 2954, 2958, 2972, 2991,
2996, 2997, 3004, 3014, 3019, 3025,
3027, 3039, 3049, 3053, 3066, 3068,
3069, 3075, 3076, 3077, 3079, 3087,
3092, 3097, 3102, 3105, 3109, 3111,
3112, 3114, 3125, 3131, 3134, 3137,
3142, 3153, 3154, 3161, 3165, 3168,
3174, 3179, 3181, 3186, 3203, 3209,
3211, 3212, 3213, 3214, 3215, 3223,
3224, 3225, 3239, 3241, 3244, 3245,
3254, 3255, 3257, 3261, 3264, 3267,
3272, 3286, 3292, 3297, 3302, 3305,
3318, 3319, 3323, 3324, 3342, 3349,
3354, 3361, 3365, 3367, 3377, 3392,
3402, 3403, 3413, 3414, 3417, 3418,
3422, 3423, 3424, 3426, 3427, 3443,
3452, 3453, 3456, 3461, 3471, 3474,
3477, 3479, 3484, 3501, 3504, 3514,
3515, 3516, 3519, 3524, 3533, 3534,
3542, 3547, 3564, 3565, 3568, 3569,
3572, 3574, 3583, 3595, 3597, 3601,
3602, 3622, 3634, 3651, 3657, 3666,
3667, 3672, 3675, 3679, 3695, 3696,
3701, 3709, 3711, 3731, 3745, 3751,
3773, 3781, 3825, 3829, 3832, 3835,
3862, 3899, 3922, 3924, 3942, 3949,
3978, 3979, 4001, 4036, 4059, 5008,
50941, 2933A, 70-4117, 70-4185, 3744, 3749,
340258, 340262, 2956, 2963, 3579, 3582,
3587, 3592, 3663, 2773, 2815, 2964,
3046, 3217, 3308, 3334, 3724, 3917,
3598, 3752, 3373, 3561, 104744, 3042,
3158, 3191, 3284, 3291, 3295, 3356,
3378, 3382, 3406, 3407, 3469, 3619,
3638, 3641, 3645, 3742, 3919, 70-4173,
3612, 3824, 3995, 3732, 2869, 3219,
3343, 3502, 3861, 2871, 3268, 70-4126,
2753, 2808, 2928, 2987, 3026, 3032,
3037, 3047, 3117, 3201, 3234, 3346,
3398, 3431, 3522, 3545, 3599, 3649,
3703, 3704, 3767, 3814, 5063, 2782,
2783, 2796, 2829, 2832, 2833, 2851,
2854, 2866, 2891, 2938, 2942, 2944,
2945, 2948, 2967, 2973, 2989, 2994,
3031, 3033, 3034, 3044, 3072, 3081,
3091, 3093, 3094, 3098, 3106, 3127,
3128, 3129, 3144, 3145, 3155, 3182,
3199, 3231, 3259, 3332, 3333, 3348,
3351, 3362, 3387, 3399, 3438, 3467,
3539, 3549, 3552, 3578, 3614, 3686,
3693, 3763, 4013, 2957, 3307, 3395,
3444, 3936, 2862, 2976, 3642, 3833,
4099, 4131, 4232, 70-4131, 70-4308, 2793,
2805, 2918, 3202, 3499, 3571, 3577,
3684, 3714, 3718, 3725, 3768, 3786,
3794, 3958, 3972, 3977, 3999, 4042,
4075, 5073, 98943, 102842, 340274, 70-4264,
70-4194, 3311, 3369, 3401, 2785, 2992,
3107, 3135, 3183, 3326, 3372, 3396,
3408, 3416, 3421, 3475, 3689, 3961,
4039, 5036, 70-4133, 70-4271, ZTVK00010,
104, 2844, 2908, 3022, 3058, 3143,
3148, 3157, 3184, 3187, 3189, 3193,
3233, 3237, 3256, 3262, 3278, 3315,
3327, 3336, 3359, 3366, 3436, 3488,
3513, 3518, 3521, 3526, 3529, 3531,
3536, 3668, 3677, 3717, 3813, 3819,
3822, 3839, 3844, 3867, 3868, 3872,
3876, 3902, 3943, 3984, 3985, 3991,
4033, 4043, 4047, 4055, 4057, 4085,
4105, 5007, 5010, 5021, 5050, 5066,
5079, 5090, 70-4101, 70-4102, 70-4187,
70-4204, 70-4206, 70-4219, 70-4225, 70-4227,
70-4247, 70-4252, 70-4266, 70-4275, 70-4351,
70-4357, 70-4364, 3250, 4103, 70-4103, 3288,
2975, 3227, 3339, 3347, 3386, 3389,
3994, 4045, 70-4373, 3028, 3722, 4061,
70-4195, 344125, 2985, 3011, 3483, 3506,
3562, 3698, 3412, 3002, 3273, 3276,
3489, 3492, 2916, 2917, 2922, 2978,
2979, 3005, 3007, 3067, 3085, 3115,
3119, 3149, 3176, 3248, 3265, 3299,
3455, 3459, 3462, 3464, 3468, 3511,
3558, 3573, 3586, 3632, 3646, 3669,
3762, 3766, 3782, 3818, 3831, 3853,
3915, 3947, 3959, 3976, 3993, 4051,
4076, 4239, 5047, 340203, 70-4116, 70-4156,
70-4162, 70-4198, 70-4205, 70-4208, 70-4212,
70-4237, 70-4255, 70-4279, 70-4315, 70-4318,
70-4322, 70-4326, 70-4341, 70-4376, 3043,
3594, 340180, 3746, 340263, 3384, 3146,
3283, 70-4282, 2897, 2902, 2904, 2993,
3249, 3626, 3628, 3893, 4004, 3727,
3728, 3441, 70-4327, 2905, 3121, 3123,
3177, 3216, 3584, 3757, 3828, 3312,
3317, 2882, 3279, 3734, 4218, 70-4218,
2924, 3024, 3606, 3608, 3909, 70-4139,
70-4141, 70-4251, 2797, 2883, 2903, 2919,
2923, 2986, 3036, 3095, 3122, 3159,
3172, 3242, 3391, 3454, 3466, 3543,
3553, 3556, 3621, 3636, 3653, 3654,
3661, 3662, 3713, 3772, 3967, 3969,
4006, 4028, 4109, 5045, 5046, 70-4112,
70-4192, 70-4285, 2878, 3017, 3329, 2872,
2966, 3064, 3797, 3897, 5013, 2892,
3008, 3074, 3218, 3226, 3375, 3486,
3567, 3493, 3003, 3507, 3735, 3759,
4086, 5003, 340264, 70-4256, 3113, 3238,
3405, 3465, 3481, 3691, 3706, 3708,
3719, 3721, 340251, 298700097, 302600003,
303200005, 303700007, 304700009, 311700023,
334600031, 3411, 3887, 3525, 3544,
70-4302.
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions USA, Inc., Concord, CA,
REASON Mistreatment of radiation
therapy due to inadvertent parameter changes or miss-calibration in Service
Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle.
This leads to patient mistreatment and alteration of future treatment plans. A
second reason is an unplanned Dosimetry calibration data set can be erroneously
copied during "Service Mode."
VOLUME OF PRODUCT IN
COMMERCE 2.123 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937,
2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32,
2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2,
2377062-5, 2377062-8;
CODE
Units:
UNK2377062-803 00000000WOA001 00000000WOA002 00000000WOA004 00000000WOA006
00000000WOA008 00000000WOA011 00000000WOA012 00000000WOA013 00000000WOA014
00000000WOA016 00000000WOA017 00000000WOA018 00000000WOA020 00000000WOA021
00000000WOA024 00000000WOA025 00000000WOA026 00000000WOA028 00000000WOA029
00000000WOA036 00000000WOA039 00000000WOA041 52 328 343 350 353 373 379 459 491
6097 00000000123YR0 00000000130YR5 00000000140YR4 00000000141YR2 00000000462YR2
00000000531YR4 00000000533YR0 00000000538YR9 00000000541YR3 00000000543YR9
00000000760YR9 00000000768YR2 1234567 00000002567M66 00000002744M61
00000002855M65 00000002856M63 00000003132YR8 00000003133YR6 00000003136YR9
00000005287GQ8 00000005289GQ4 00000005754GQ7 00000008131GQ5 13001050
00000018702YM2 00000063512WM8 00000063543WM3 00000203651MR5 00000205000MR3
00000205002MR9 00000205003MR7 00000209913MR3 00000213184MR5 00000213650MR5
00000213922MR8 00000213923MR6 00000215368MR2 00000216696MR5 00000217593MR3
00000218866MR2 00000218868MR8 00000225874MR7 00000229973MR3 00000229975MR8
00000229976MR6 00000230905MR2 00000232332MR7 00000232336MR8 00000235914MR9
00000236103MR8 00000237054MR2 00000237055MR9 00000239848MR5 00000241286MR4
00000243208MR6 00000246318MR0 00000246985MR6 00000249644MR6 00000250618MR6
00000250977MR6 00000254964MR0 00000254965MR7 00000258360MR7 00000259587MR4
00000261946MR8 00000264768MR3 00000265078MR6 00000265081MR0 00000266430MR8
00000267348MR1 00000268655MR8 00000269066MR7 00000269929MR6 00000277562MR5
00000801097YM7 00000801105YM8 00000801109YM0 00000801190YMO 00000801200YM7
00000811705YM3 00000813944YM6 00000820858YM9 00000830906YM4 00000830908YM0
00000830918YM9 00000830920YM5 00000830924YM7 00000830925YM4 00000831059YM1
00000831068YM2 00000831069YM0 00000837348YM2 00000869948YM0 00000897259YM8
00000897716YM7 00000908879YM0 00000908880YM8 00000908881YM6 00000908883YM2
00000908885YM7 00000908886YM5 00000908887YM3 00000908894YM9 00000908895YM6
00000908896YM4 00000918699YM0 00000918700YM6 00000918701YM4 00000918703YM0
00000918704YM8 00000918708YM9 00000918709YM7 00000918710YM5 00000918711YM3
00000919518YM1 00000952556YM9 00000952559YM3 00000956447YM7 00000956449YM3
00000956450YM1 00000956453YM5 00000956456YM8 00000956460YM0 00000956461YM8
00000956462YM6 00000956464YM2 00000965437YM7 00000965787YM5 00000965825YM3
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE
Healthcare, Waukesha WI,
Manufacturer: GE Hangwei Medical Systems Co., LTD, Beijing PR, China.
REASON
Incorrect patient
positioning; when moving the patient into the bore may lead to wrist and hand
injury.
VOLUME OF PRODUCT IN COMMERCE 163
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Ximatron
Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology
Information System, Varian Medical Systems,
CODE Serial numbers H720441, H720637,
H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895,
H720916, H720932, H720973
RECALLING
FIRM/MANUFACTURER Varian Medical Systems, Inc., Palo Alto, CA,
REASON Unexpected loss of Treatment Field Add-Ons
(Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment
field is created without an MLC, but with an add-on, the add on will be deleted
without warning. If this is not detected and corrected, incorrect dose delivery
will occur.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION MO, NY and
Internationally
PRODUCT Texium
Closed Male Luer (CML), Model Number: 10012241,
CODE No serial numbers. Model number
only.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA,
Manufacturer: Cardinal Health 303, Inc., Creedmoor, NC.
REASON
Leaks. There is
a risk of leakage at the female end of the Texium closed male luer (CML) when
attached to a spin luer. (NOTE: users who connect the female portion of the
Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes
are not affected by this issue).
VOLUME OF PRODUCT IN
COMMERCE 76,300
units
DISTRIBUTION Nationwide, Australia, Canada, Japan
and
Switzerland
PRODUCT OPTI®
LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic,
CODE
Lot numbers 701800, 706800, 710801,
711800, 711801, 712800, 713800, 714800, 714801, 714802, and
718800
RECALLING FIRM/MANUFACTURER OPTI Medical Systems,
Inc., Roswell, GA
REASON Incorrect results/stability
failure; Actual device stability studies show sodium and chloride sensors age
differently than anticipated when stored at the high end of labeled storage,
therefore subsequent measurements give results outside the allowed error
allowance before the 6 month expiration date shown on the
device.
VOLUME OF PRODUCT IN COMMERCE 289 boxes pf 25
cassettes
DISTRIBUTION Nationwide and Internationally
PRODUCT Medtronic
Paceart System, 2006 Edition, The Paceart System can act as a Practice
Management software application and is intended for use by facilities that
provide services such as event monitoring, trans-telephonic pacemaker
evaluation, and in-office evaluation of implanted cardiac devices;
CODE
2006 First Edition (Get
Connected Edition)
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN,
Manufacturer: Medtronic
Paceart, Arden Hills, MN.
REASON An issue with
the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under
certain circumstances, Paceart System Generic ICD reports may not accurately
reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data.
When episode detection data is imported into the Paceart System from certain
sources, the Paceart System Generic ICD reports display a zero, suggesting no
episodes have occurred, instead of indicating that no data is
available.
VOLUME OF PRODUCT IN COMMERCE 721
units
DISTRIBUTION Nationwide
WEEK ENDING NOVEMBER 24
PRODUCT
a)
Philips Medical System - BV Pulsera Mobil C-arms with Remote Control Option,
b) Philips Medical System -
Endura X-Ray Systems (Release 2) with Remote Control
Option,
CODE
a) 21, 22, 30, 283,
284, 47, 51, 48, 301, 63, 73, 58, 46, 265, 267, 266, 87, 88, 89, 90, 91, 92, 93, 94, 96, 97, 86, 107, 108, 120, 132, 141, 148,
177, 193, 155, 156, 157, 158, 159, 160, 161, 162, 163,
164, 165, 166, 167, 168, 169, 170, 172, 173, 174, 175,
185, 121, 176, 188, 195, 186, 187, 197, 198, 206, 201, 203, 204, 205, 213, 207,
208, 209, 226, 229, 251, 244, 245, 248, 249, 250, 253,
254, 258, 275, 278, 287, 288, 292, 289, 306, 305, 304,
294, 296, 297, 331, 330, 302, 309, 310, 320, 366, 367, 339, 329, 337, 332, 333, 347, 348, 349,
350, 342, 398, 397, 401, 400, 399, 356, 354, 368, 374,
357, 379, 371, 370, 369, 358, 363, 359, 385, 373, 388, 387, 386, 396, 390, 362,
389, 391, 392, 423, 415, 428, 438, 421, 433, 432, 427,
410, 417, 416, 420, 429, 424, 471, 443, 444, 440, 598,
441, 483, 481, 482, 408, 402, 405, 411, 406, 407, 403, 409, 404,
446, 515, 447, 448, 449, 450, 451, 452, 454, 455, 456, 457, 458, 459, 460,
461, 462, 463, 465, 466, 469, 470, 472, 475, 476, 477,
509, 528, 506, 505, 523, 534, 504, 537, 507, 502, 500,
499, 501, 473, 474, 518, 521, 520, 642, 519, 641, 526, 525, 536, 533, 557, 543, 468, 552, 553, 571, 555, 556, 577, 559, 620,
558, 579, 570, 599, 575, 635, 633, 634, 580, 625, 624,
597, 636, 589, 674, 639, 638, 590, 637, 640, 631, 630, 593, 594, 595, 632, 1089, 645, 621, 644, 623, 587, 588, 627,
648, 649, 659, 667, 656, 661, 662, 663,
665, 670, 678, 672, 675, 677, 679, 680, 684, 682, 683, 693, 694, 696, 709, 695, 707, 723, 951, 704, 710, 717, 705, 718, 708, 720,
719, 712, 724, 725, 726, 727, 728, 772, 611, 602,
711, 603, 729, 738, 612, 613, 730, 605, 735, 736, 737, 615, 614, 607, 606, 745, 762, 739, 760, 608, 604, 756, 763, 764,
765, 752, 750, 755, 754, 609, 812, 766, 788, 767, 761,
616, 781, 780, 779, 757, 748, 747, 746, 749, 807, 806, 769, 784, 619, 617, 610, 778, 787, 768, 789, 956, 774, 795,
792, 794, 878, 881, 805, 776, 777, 773, 618, 796, 798,
831, 791, 830, 1069, 819, 793, 790, 800, 820, 797, 823, 826, 822, 818, 815, 817, 821, 839, 877, 829, 833, 834,
832, 825, 931, 840, 845, 857, 849, 850, 851, 852, 853,
854, 855, 856, 846, 847, 848, 864, 865, 866, 867, 868, 869,
870, 871, 858, 859, 860, 861, 862, 863, 838, 837, 893,
897, 885, 944, 937, 892, 844, 879, 880, 875, 904, 876,
886, 936, 896, 888, 889, 890, 894, 895, 938, 887, 915, 898, 899, 942, 939, 923, 932, 933, 921, 901, 914, 920, 913, 912,
955, 902, 903, 943, 924, 916, 905, 935, 926, 906, 910,
909, 918, 917, 919, 929, 930, 941, 940, 947, 948, 908, 950, 960, 954, 957, 958, 962, 963, 966, 967, 975, 969, 971,
972, 999, 973, 974, 1038, 976, 1010, 1022, 1021, 977,
978, 979, 983, 1008, 1020, 1023, 1015, 988, 1014, 1018, 1003,
1004, 990, 984, 1009, 996, 1001, 1024, 643, 1039, 985, 1019, 995, 997,
1025, 1026, 998, 1027, 1028, 1002, 986, 987, 1041, 1029,
989, 1078, 1013, 1037, 426, 1017, 1034, 1035, 1042, 1033,
1036, 1070, 1083, 1307, 1062, 1080, 1071, 1072, 1087, 1120, 1082, 1373, 1358, 1094, 1333, 1095, 1363, 1334, 1107, 1359,
1326, 1105, 1106, 1369, 1365, 1375, 1111, 1112, 1376,
1374, 1297, 1304, 1305;
b) 90, 105, 118, 119, 135, 171, 175, 176, 222, 218,
227, 226, 232, 233, 241, 248, 249, 256, 261, 262, 276,
277, 282, 303, 302, 316, 313, 304, 311, 312, 320, 327, 334, 333, 343, 345, 396
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North
America Co. Phillips, Bothell, WA,
Manufacturer: Philips Medical Systems
Nederlands, Best,
Netherlands. REASON System Shut Down -- Unexpected Shut Down during
use of the Optional Remote Control.
VOLUME OF PRODUCT IN
COMMERCE 633 total devices: 37 BV Endura, 596 BV
Pulsera
DISTRIBUTION Nationwide
PRODUCT SmartSeal
Wedge Femoral Pressurizer; Product Code/Catalog No: 3206002. This product allows
for effective and controlled pressurization of bone cement into the femur and
the acetabulum during hip arthroplasty procedures,
CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw,
IN,
Manufacturer: Depuy CMW, Blackpool, Lancashire, UK.
REASON
Package Integrity: The outer
peelable pouch seals may be compromised due to creasing, although the inner
pouch seals are intact.
VOLUME OF PRODUCT IN
COMMERCE 3,530
units
DISTRIBUTION Nationwide
PRODUCT GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with
Regular and Super 9800 and 9600 Arm Systems,
CODE Serial numbers: IT35052, IT35070,
IT35108, IT35109, IT35129, IT35130, IT35132, IT35133, IT35134, IT35139, IT35146,
IT35152, IT35166, IT35169P-RC-1, IT35173, IT35179P, IT35181, IT35185P-G-RC,
IT35187P, IT35189P, IT35193P, IT35214P, IT35216P, IT35223P, IT35225P, IT35226P,
IT35234P, IT35244P, IT35245P, IT35251P, IT35269P, IT35280P, IT35286P, IT35289P,
IT35292P, IT35293P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35311P,
IT35312P, IT35316P, IT35323P, IT35324P, IT35330P, IT35339P, IT35344P, IT35375P,
IT35377P, IT35379P, IT35381P, IT35382P, IT35383P, IT35406G, IT35435G, IT35458G,
IT35468G. Two numbers unavailable.
RECALLING
FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake
City UT
REASON Tracking Accuracy - Image intensifier
supplier's change on the C-Arm could lead to patient injury, due to incorrect
anatomical location of the instrument during a procedure.
VOLUME OF
PRODUCT IN COMMERCE 61
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Clarisonic
Skin Care System - A hand held cleansing device for the skin. The Unit comes
with a charger cradle for charging the device. CODE All codes prior to
07177xx
RECALLING FIRM/MANUFACTURER Pacific Bioscience
Lab, Inc., Bellevue, WA,
REASON Overheating: The
handle or charger/cradle can overheat, melting the plastic, which potentially
can lead to smoke and fire and has caused mild user burns.
VOLUME OF
PRODUCT IN COMMERCE 101,513
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Product
Description : GE OEC, Insta Trak 3500 Plus with the Cranial Application for
Image Guided Surgery,
CODE Not
applicable
RECALLING FIRM/MANUFACTURER GE OEC Medical
Systems, Inc., Salt Lake City, UT
REASON Crack, Fracture or
Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may
become detached from the unit and enter into the surgical
field.
VOLUME OF PRODUCT IN COMMERCE 169
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Stryker
T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S,
Sterile,
CODE Lot:
K871252
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Howmedica Osteonics Corp., Mahwah, NJ,
Manufacturer: Stryker Trauma GmbH,
Schonkirchen, Germany.
REASON Mislabeled: One lot
of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm
length screws.
VOLUME OF PRODUCT IN COMMERCE 50
units
DISTRIBUTION Nationwide
PRODUCT
a)
Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000,
b) Matrix MAX3 Actuator, Catalog
Number: MAX30 A300545A2510V000,
c) Matrix MAX3 Actuator, Catalog Number: MAX30
A300515A254L000,
CODE
a) Serial number L03684171;
b) Serial
number 3337328;
c) Serial number 3072047
RECALLING
FIRM/MANUFACTURER
Recalling Firm: SKF USA Inc., Norristown, PA,
Manufacturer: Magnetic
Elektromotoren, Liestal, Switzerland.
REASON Sudden failure of the actuator during
lifting operation.
VOLUME OF PRODUCT IN COMMERCE 1,298
units
DISTRIBUTION IA, MN, NE, NY, and
OH
PRODUCT
a)
Stryker Zoom (Atlas) powered patient transport stretcher, Model 660,
b) Stryker Transport
wheeled stretcher, Model 720,
c) Stryker Transport
wheeled stretcher, Model 721,
d) Stryker OEM wheeled
stretcher, Model 722,
e) Stryker Transport wheeled
stretcher, Model 735 (ST104),
f) Stryker Advantage
Series Emergency Care wheeled stretcher, Model 1001,
g) Stryker Trauma wheeled stretcher, Model 1002,
h) Stryker M-Series wheeled stretcher, Model 1005 (SM104),
i) Stryker Advantage Series Emergency Care wheeled
stretcher, Model 1009,
j)
Stryker M-Series wheeled stretcher, Model 1015 (SM204),
k) Stryker Trauma wheeled stretcher, Model 1020,
l) Stryker M-series powered patient transport stretcher, Model
1025 (SM304),
m) Stryker Eye
Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069,
n) Stryker Renaissance
Series Emergency Care wheeled stretcher, Model 1210,
o) Stryker Renaissance
Series Emergency Care wheeled stretcher, Model 1211,
p) Stryker Renaissance
Series Emergency Care wheeled stretcher, Model 1231,
q) Stryker Renaissance
Series/Advantage Series PACU wheeled stretcher, Model 1501,
r) Stryker Renaissance
Series/Advantage Series PACU wheeled stretcher, Model 1509,
s) Stryker Renaissance Series
PACU wheeled stretcher, Model 1710,
t) Stryker Renaissance Series PACU wheeled stretcher, Model
1711,
u) Stryker
Renaissance Series PACU wheeled stretcher, Model 1731,
CODE
All stretchers with
serial numbers beginning with 0309 through 0505.
RECALLING
FIRM/MANUFACTURER Stryker Medical Div. of Stryker Corporation,
Portage MI
REASON The brake cams may crack or develop
excessive wear, resulting in the brakes not locking the wheels, or the stretcher
not being locked firmly in position.
VOLUME OF PRODUCT IN
COMMERCE 81,367 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Hill-Rom
VersaCare Hospital Bed System; Models P3200 and P3201,
CODE
Serial numbers E322AD0046 through
H023AD6179. (E means 2003 production, F means 2004 production, G means 2005
production and H means 2006 production).
RECALLING
FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN,
REASON
False Latch/Failure to Latch-The side
rail may not latch, or the latch may not fully engage, resulting in the side
rail being able to be lowered without pulling on the release
handle.
VOLUME OF PRODUCT IN COMMERCE 43,731
beds
DISTRIBUTION Nationwide and Internationally
PRODUCT
a)
NEMIO Ultrasound System, Model SSA-550A , Software versions:
V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0,
V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0,
V4.3.0, V4.5.0, V4.5.000A,
b) NEMIO XG Ultrasound
System, Model SSA-580A , Software versions: VI .5.0, Vl
.5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008
CODE
a)
Serial numbers: C1592849 E2524072 E2524073 E2524074 E2524075 E2524076 E2524077
E2524078 E2524079 E2524080 E2524081 E2524082 E2524083 E2524084 E2524085 E2524086
E2534236 E2534237 E2534238 E2534239 E2534240 E2534241 F2534286 F2534287 F2534288
F2534289 F2534290 F2534291 F2534292 F2544351 F2544352 F2544353 F2544354 F2544355
F2544356 F2544357 F2544358 F2544427 F2544428 F2544429 F2544430 F2544431 F2544432
F2544433 F2544451 F2544452 F2544453 F2544505 F2544506 F2544507 F2544508 F2544509
F2544510 F2544511 F2544512 F2544513 F2544514 F2544515 F2544516 F2544517 F2544518
F2544519 F2544520 F2544521 F2544522 F2544523 F2544524 F2544525 F2544526 F2564733
F2564734 F2564735 F2564736 F2564737 F2564738 F2564739 F2564740 F2564741 F2564742
F2564743 F2564744 H2626535 H2626536 H2626537 H2626538 H2626539 H2626540 H2626541
H3516932 H3516933 H3516934 H3516935 H3516936 H3516937 I3522331 I3522332 I3522333
I3522334 I3522335 I3522336 I3522337 I3522338 I3522339 I3522340 I3522341 I3522342
I3522343 I3522344 I3522345 I3522346 I3522347 I3522348 I3522505 I3522506 I3522507
I3522508 J3542933 J3542934 J3542935 J3542936 J3542937 J3542938 J3542939 J3542940
J3543085 J3543086 J3543087 J3543088 J3543089 J3543090 J3543091 J3543092 J3553299
J3563308 J3563491 J3563492 J3563493 J3573564 J3573565 J3573566 J3573568 J3573569
J3573570 J3573571 J3573755 J3573756 J3573757 J3573759 K3594276 K3594277 K3594278
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K4532035 K4532036 K4532037 K4532038 K4532039 K4532040 K4532041 K4532042 K4532043
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K4536957 K4536958 L4542242 L4542244 L4542245 L4542315 L4542316 L4552586 L4552587
L4552588 L4573185 L4573186 L4573187 L4573188 L4573189 L4573391 L4573392 L4573393
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M4615118 M4615119 M4615120 M4615307 M4615308 M4625540 M4625541 M4625665 M4625729
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N5526342 N5526344 N5526345 N5526477 N5526478 N5526479 N5526480 N5536592 N5536593
N5536594 N5536595 N5536596 N5536597 N5536598 N5536599 N5536600 N5536601 N5536702
N5536703 N5536704 N5536705 N5536810 N5536811 N5536812 N5536813 N5536814 N5536815
N5536816 N5536817 N5536818 N5536819 N5536820 N5536821 N5536822 N5536823 N5536824
N5536825 N5536826 O5542122 O5542123 O5542208 O5542209 O5542210 O5542211 O5542212
O5542213 O5542214 O5542215 O5542216 O5542217 O5542218 O5542219 O5542220 O5542308
O5542309 O5552383 O5552384 O5552385 O5552386 O5552387 P5573253 P5573256 P5573257
P5573258 P5573259 P5593754 P5593755 P5593756 P5593757 P5593758 P5593759 P5593764
P5593765 P5604059 P5604060 P5604061 P5604062 P5604133 P5604134 P5604138 P5604139
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B1552338 B1552339 B1552340 B1552341 B1552342 B1552343 B1552344 B1552345 B1552346
B1552348 B1552349 B1552350 C1572408 C1572409 C1572410 C1572411 C1572412 C1572413
C1572414 C1572415 C1572416 C1572417 C1572418 C1572419 C1572420 C1572421 C1572422
C1572423 C1572425 C1572426 C1572427 C1572428 C1572429 C1572430 C1572431 C1572432
C1572433 C1572434 C1572435 C1572436 C1572437 C1572458 C1572459 C1572460 C1572461
C1572462 C1572463 C1572464 C1572465 C1572466 C1572467 C1572468 C1572469 C1572470
C1572471 C1582540 C1582541 C1582543 C1582544 C1582545 C1582546 C1582547 C1582548
C1582550 C1582551 C1582552 C1582578 C1582579 C1582580 C1582581 C1582582 C1582583
C1582584 C1582585 C1582586 C1582587 D1602981 D1602982 D1602983 D1602985 D1602986
D1602987 D1602988 D1602989 D1602990 D1602991 D1602992 D1602993 D1602994 D1602995
D1602996 D1602997 D1613133 D1613134 D1613135 D1613136 D1613137 D1613138 D1613139
D1613140 D1613141 D1613142 D1623336 D1623337 D1623338 D1623339 D1623340 D1623341
D1623342 D1623343 D1623344 D1623345 E2524139 E2524140 E2524141 E2524142 E2524143
E2524144 E2524145 E2524146 E2524148 E2524155 F2554618 F2554619 F2554620 F2554621
F2554622 F2554623 F2554624 F2564672 F2564673 F2564674 F2564675 F2564676 F2564677
F2564697 F2564698 F2564699 G2574883 G2574884 G2574885 G2574886 G2574887 G2574888
G2574889 G2574890 G2574891 G2574892 G2574893 G2574894 G2574895 G2585178 G2585179
G2585180 G2585181 G2585182 G2585183 G2585184 G2585185 G2585196 G2585197 G2585198
G2585199 G2585200 G2585201 G2585202 G2585203 G2585324 H2585516 H2585517 H2585518
H2585519 H2585520 H2585521 H2585522 H2585523 H2605828 H2605829 H2605830 H2605831
H2605832 H2605833 H2605834 H2605835 H2605836 H2605837 H2616223 H2616224 H2616225
H2616226 H2616227 H2616313 H2616314 H2616315 H2616316 H2616317 H2616318 H2616319
H2616320 H2616357 H2616358 H2616359 H2626461 H2626462 H2626463 H2626464 H2626465
H2626466 H2626467 H3516836 H3516837 H3516838 H3516839 H3516840 H3516841 H3516842
H3516843 H3516844 H3516845 H3516846 H3516847 H3516848 H3516849 H3516850 H3516991
H3516992 H3516993 H3516994 H3516995 I3522293 I3522294 I3522295 I3522296 I3522297
I3522298 I3522299 J3542925 J3542926 J3542927 J3542928 J3542929 J3543008 J3543009
J3543010 J3543012 J3543018 J3543019 J3543020 J3543021 J3553153 J3553154 J3553155
J3553234 J3553235 J3553236 J3573529 J3573721 J3573722 J3573723 J3573724 J3583864
J3583865 J3583866 J3583867 J3583868 J3583869 J3583870 J3583871 J3583872 J3583873
J3594187 K3594186 K3604635 K3604636 K3604637 K3604638 K3604639 K3604640 K3604641
K3604642 K3604645 K3604646 K3604647 K3604648 K3615095 K3615096 K3615100 K3615101
K3615102 K3615103 K3615104 K3615105 K3615106 K3615107 K3615108 K3615109 K3615110
K3615111 K3615112 K3615113 K3615114 K3615115 K3615116 K3615117 K3615118 K3615119
K3615120 K3615121 K3615123 K3625433 K3625434 K3625435 K3625436 K3625437 K3625444
K3625446 K3625447 K3625448 K3625450 K3625451 K3625452 K3625453 K3625454 K3625455
K3625456 K3625457 K3625654 K3625655 K3625656 K3625657 K3625658 K4516171 K4516173
K4516175 K4516177 K4516178 K4516180 K4516182 K4516183 K4516184 K4516185 K4516186
K4516188 K4516189 K4516388 K4516389 K4516391 K4516395 K4526793 K4526795 K4526796
K4526797 K4526798 K4526799 K4526800 K4532067 K4532068 K4532069 K4532070 K4532071
K4532072 K4532073 K4532074 K4532075 K4536911 K4536912 K4536913 K4536915 K4536917
K4536918 L4532118 L4542273 L4542398 L4542400 L4542402 L4542403 L4552683 L4552684
L4562757 L4562758 L4562759 L4562760 L4562761 L4562762 L4562849 L4562850 L4562925
L4563013 L4563014 L4563016 L4573115 M4594495 M4604596 M4604597 M4604701 M4604702
M4604703 M4604704 M4604705 M4604706 M4604707 M4614981 M4614982 M4614984 M4614985
M4615047 M4615050 M4615051 M4615052 M4615054 M4615055 M4615059 M4615060 M4615061
M4615062 M4615063 M4615064 M4615065 M4615066 M4615067 M4615169 M4615170 M4615171
M4615172 M4615173 M4615174 M4615278 M4615348 M4615349 M4615350 M4615351 M4615352
M4615353 M4615354 M4615355 M4615356 M4625402 M4625403 M4625404 M4625476 M4625477
M4625479 M4625480 M4625481 M4625482 M4625484 M4625485 M4625487 M4625488 M4625490
M4625493 M4625494 M4625495 M4625496 M4625497 M4625498 M4625499 M4625500 M4625501
M4625502 M4625503 M4625504 M4625505 M4625592 M4625593 M4625594 M4625595 M4625597
M4625598 M4625599 M4625600 M4625601 M4625602 M4625603 M4625604 M4625605 M4625606
M4625607 M4625613 M4625614 M4625615 M4625616 M4625617 N5515775 N5515786 N5515787
N5515788 N5515790 N5515792 N5515793 N5515794 N5515796 N5515799 N5515852 N5515853
N5515855 N5515856 N5516031 N5526138 N5526139 N5526140 N5526141 N5526142 N5526143
N5526144 N5526278 N5526279 N5526280 N5526281 N5526282 N5526283 N5526284 N5526379
N5526380 N5526381 N5526382 N5526383 N5526384 N5526385 N5536560 N5536561 N5536562
N5536563 N5536564 N5536565 N5536566 N5536567 N5536568 N5536569 N5536616 N5536617
N5536618 N5536619 N5536620 N5536621 N5536622 N5536623 N5536624 N5536625 N5536636
N5536637 N5536638 N5536639 N5536640 N5536641 N5536642 N5536643 N5536644 N5536645
N5536766 O5542018 O5542020 O5542021 O5542022 O5542025 O5542026 O5542027 O5542028
O5542030 O5542032 O5542033 O5542034 O5542035 O5542037 O5542038 O5542040 O5542041
O5542042 O5542154 O5542155 O5542158 O5542159 O5542160 O5542161 O5542162 O5542165
O5542166 O5542167 O5542170 O5542171 O5542260 O5542268 O5542269 O5542270 O5542271
O5542272 O5542273 O5542274 O5542321 O5552431 O5552432 O5552433 O5552434 O5552435
O5552436 O5552437 O5552493 O5552494 O5572855 O5572856 O5572857 O5572858 O5572859
O5572860 O5572861 O5572862 O5572863 O5572864 P5573154 P5573155 P5573160 P5573161
P5573162 P5573163 P5573165 P5573166 P5573212 P5573262 P5583288 P5583289 P5583290
P5583565 P5593628 P5593629 P5593630 P5593631 P5593632 P5593633 P5593634 P5593635
P5593636 P5593637 P5593684 P5593685 P5593686 P5593687 P5593688 P5593689 P5593690
P5593691 P5593785 P5593786 P5593787 P5593788 P5593789 P5593790 P5593791 P5593792
P5593793 P5593794 P5593795 P5593796 P5593797 P5593798 P5593799 P5593800 P5593801
P5603876 P5603963 P5603970 P5603972 P5604085 P5604086 P5604087 P5604088 P5604089
P5604090 P5604091 P5604176 P5614296 P5614297 P5614298 P5614302 P5614303 P5614305
P5614306 P5614307 P5614308 P5614309 P5614441 P5614491 P5614492 P5614493 P5614494
P5614495 P5614496 P5614497 P5614498 P5614499 P5614500 P5624564 P5624565 P5624722
P5624723 P5624724 P5624725 P5624727 P5624728 P5624729 P5624730 P5624731 P5624732
P5624733 P5624734 P5624735 P5624736 P5624738 P5624823 P5624824 P5624825 P5624826
P5624827 P5624890 P5624891 P5624892 P5624893 P5624894 P6514922 P6514923 P6514924
P6514925 P6514926 P6514927 P6514928 P6514929 P6514930 P6514931 P6514932 P6514933
P6514934 P6514935 P6514936 P6514937 P651505