MAY
2007
WEEK ENDING MAY 5
PRODUCT Prosthetic Knee
Joint (for external prosthesis, not implant), CODE Serial numbers 22509, 24208, 2326D, 2334C, 2337F,
2339H, 2341A 2342B
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Medi Manufacturing Inc., Whitsett, NC,
Manufacturer: Medi
Bayreuth, Bayreuth, Germany.
REASON Joints contain a component
manufactured with an alloy that may not comply with manufacturer's
specifications.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION Nationwide
PRODUCT Puritan Bennett 840
Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX,
4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs
indicate any combination of alpha characters which specify option and language
packs),
CODE
Serial Numbers: 0619450019
0619450065 0619450072 0619450136 0619450214 0619450387 0619450402 0619460020
0620450072 0620450211 0620450224 0621450055 0621450106 0621450152 0623450106
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3510070329
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Nellcor Puritan Bennett, Pleasanton, CA,
Manufacturer: Puritan Bennett Ltd.,
Mervue,
Ireland.
REASON In rare
instances, the safety valve may remain open after an occlusion is resolved. If
the safety valve does not reset, the ventilator will detect a circuit disconnect
condition. When this happens, the ventilator will annunciate a high-urgency
audible alarm and the ventilator will not resume normal operation.
VOLUME
OF PRODUCT IN COMMERCE 3,756 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Medfusion 3500
Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3
and 4.1.4,
CODE Model 3500 pump with 4.1.4 or
4.1.3 software.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Smiths Medical MD, Inc., Saint Paul, MN
Manufacturer: Medex Inc, Duluth, GA.
REASON
Software anomaly that causes the pump to experience
a sudden and unexpected failure. This anomaly occurs during the pump's startup
sequence when the pump's Preventative Maintenance Alarm goes off, preventing the
pump from completing its power up routine. Lock-up occurs and the pump will not
function.
VOLUME OF PRODUCT IN COMMERCE 23,519
units
DISTRIBUTION Nationwide, Canada and Italy
PRODUCT Magnetom Espree
System with OR Table, Model number 10092082,
CODE Serial number 1002, 1003, and 1004
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc, Malvern, PA,
Manufacturer: Siemens
AG MED, Erlangen, Germany.
REASON If table top is not seated properly it can lock
up/stick.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NY and TX
Ortho-Clinical Diagnostics, Inc. Issues Recall for Cardiac Marker
Ortho-Clinical Diagnostics, Inc. has initiated a recall of two lots of a diagnostic test used by physicians to aid in the diagnosis of injury to heart muscle and/or heart attack because of shifts in test results that could contribute to a missed diagnosis of myocardial infarction.
The company initiated the recall of the VITROS® Immunodiagnostic Products Troponin I Reagent Pack, Lots 3151 and 3170, after a small number of clinical laboratories administering the test reported shifts in quality control results. An investigation by Ortho-Clinical Diagnostics determined that the potential existed for false negative troponin-I results at very low levels of troponin elevation. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have. Ortho-Clinical Diagnostics is working to identify the root cause of the reported issue.
The recall is limited to the VITROS® Immunodiagnostic Products Troponin I Reagent Pack, Lots 3151 and 3170. Clinical labs in possession of these lots have been contacted via phone, fax and overnight mail by the company and instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. The identified product lots were distributed to clinical labs in the United States and outside the U.S. between January and March of 2007. Replacement product has been provided to clinical labs with the affected product lots.
Clinical laboratories with questions may contact the company at 1-800-421-3311.
WEEK ENDING MAY 12
PRODUCT Conditional
Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2
battery packs for use in Magnetic Resonance environments; catalog number
005852300,
CODE Battery lot numbers:
065201-065228, 065231, 065232, 065233
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical,
Bannockburn, IL,
Manufacturer: Truphatek, Ltd., Netanya, Israel.
REASON
The MRI Battery is out of specification
for its magnetic content.
VOLUME OF PRODUCT IN COMMERCE 1
kit
DISTRIBUTION GA
PRODUCT 83
plus Mini-flex with accessory crate, Automatic Endoscope Reprocessor (AER) to
clean and high level disinfect ENT/Bronch/Urology scopes between patient usage,
CODE
Serial
numbers: 051305-J, 061705-E, 061605-F, and
061705-G.
RECALLING
FIRM/MANUFACTURER Custom Ultrasonics, Ivyland,PA,
REASON
The device was marketed without a
510k.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA, GA, VA, and UK
PRODUCT Nemio XG, ultrasound system, SSA-590A with version 1.5 software,
CODE
Serial #: A1A0642100; A1A0642102;
A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327;
A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285;
A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291;
A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374;
A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380;
A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc.,
Tustin, CA,
Manufacturer: Toshiba Medical
Systems Corp., Tokyo, Japan.
REASON Transducer Surface Temperature : It was found during testing that
when using the system in the 2DCDI + PW mode, with the Scale Graph function
active, that the transducer surface temperature could exceed the 27 degrees
Celsius limit as specified in the IEC safety
standard.
VOLUME OF PRODUCT IN
COMMERCE 37 units
DISTRIBUTION Nationwide
PRODUCT
Lumex®
Walkabout Lite Four-Wheel Rollator,
CODE Model numbers: RJ4300B, RJ4300D,
RF4300G, RJ4300K, RJ4300R, and Imperial model RF4400K
RECALLING
FIRM/MANUFACTURER
Recalling Firm:
Graham-Field, Inc., Bay Shore,NY,
Manufacturer: Dan Yang Ju Mad Healthcare
Equipment Co., Ltd., Jietpai Town, Dan Yang, Jiangsu, China.
REASON
The caster bolt stem/screw may
loosen over time causing the wheel to come off.
VOLUME OF PRODUCT IN
COMMERCE 13,300 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) BacT/ALERT Classic System Software, Blood Culturing System,
b) BacT/ALERT 3D System Software, Blood Culturing System,
c) BacT/ALERT 3D Combo Systems Software, Blood
Culturing System,
d) BacT/ALERT 3D 60 Systems
Software, Blood Culturing System,
CODE All Models
RECALLING
FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC,
REASON
Plastic bottle samples assigned less
sensitive default glass bottle algorithm instead of the plastic bottle algorithm
on BacT/ALERT Microbial Detection Systems.
VOLUME OF PRODUCT IN
COMMERCE 10,790 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT GEM Premier 4000 Laboratory Analyzer,
CODE
Serial numbers prior to 07020343 with
Software versions prior to V1.1.3
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Lexington, MA,
REASON Instrument in Micro Sampling Mode failed
to aspirate and no error code was generated and an incorrect patient report
could result.
VOLUME OF PRODUCT IN COMMERCE 210
units
DISTRIBUTION Nationwide and Internationally
PRODUCT American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic,
CODE
Lot Number: 061212 , Exp
2008-12-22 Lot Number: 061020, Exp 2008-10-20
RECALLING
FIRM/MANUFACTURER American Diagnostica, Inc., Stamford,CT,
REASON
Stability of product not assured. An
increase of clotting time for both normal and abnormal
plasmas.
VOLUME OF PRODUCT IN COMMERCE 96
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT Doro
Products Adapter, Product number 5979-300. The adaptor system is attached to
OSI's Spinal Frame, which is an operating room tabletop that is attached to a
table base. The Frame is used to support patients during spinal surgery,
CODE
Listing 878.4950
RECALLING
FIRM/MANUFACTURER Orthopedic Systems Inc., Union City,CA,
REASON
Material used to manufacture accessory
bracket does not meet product specification. The screw is normally composed of
''Torlon'', which is yellow. The part was made of "Tercite", which is
blue.
VOLUME OF PRODUCT IN COMMERCE 8
devices
DISTRIBUTION ID, IL, NY, and CA
PRODUCT B.Braun
HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped
in cases containing 10 sets,
CODE Lot number
0060911602
RECALLING FIRM/MANUFACTURER
Recalling
Firm: B. Braun Medical, Inc., Allentown,PA,
Manufacturer: B Braun of Puerto Rico, Inc., Sabana
Grande,PR.
REASON The
integrity of the sterile product barrier may be compromised.
VOLUME
OF PRODUCT IN COMMERCE 180
units
DISTRIBUTION Nationwide
PRODUCT
a) SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France;
b) SOPRO Camera Control Units, PAL,
SV420P, REF (Catalog) #72200506 v1.1; Made in France,
CODE
a) Serial #’s: BE, 420-8161, 420-8013,
420-8026, 420-8056, 420-8041, 420-8134, 420-8137, 420-8059, 420-8135,
420-8010, 420-8014, 420-8132, 420-8018, 420-8020, 420-8035, 420-8045,
420-8114, 420-8115, 420-8136, 420-8140, 420-8143, 420-8146, 420-8149,
420-8155, 420-8113, 420-8142, 420-8151, 420-8154, 420-8058, 420-8050,
420-8033, 420-8138, 420-8038, 420-8054, 420-8036, 420-8037, 420-8043,
420-8133, 420-8025, 420-8015, 420-8019,
420-8028, 420-8030, 420-8031,
420-8032, 420-8042, 420-8049, 420-8057, 420-8039, 420-8119, 420-8120,
420-8040, 420-8118, 420-8145, 420-8152, 420-8046, 420-8011, 420-8055,
420-8141, 420-8021, 420-8112, 420-8024, 420-8048, 420-8144, 420-8016,
420-8017, 420-8022, 420-8023, 420-8047, 420-8052, 420-8044, 420-8034,
420-8053, 420-8029, 420-8051, 420-8058;
b) Serial #’s: 420-8283, 420-8275,
420-8285, 420-9006, 420-8271, 420-8277, 420-8289, 420-9015, 420-9000,
420-9001, 420-9002, 420-9004, 420-9005, 420-9007, 420-9008, 420-9009,
420-9010, 420-9012, 420-9014, 420-9016, 420-9017, 420-9018, 420-9019,
420-8282 and 420-9013
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc Endoscopy
Division, Oklahoma City,OK,
Manufacturer: Sopro Zac Athelia IV, La Ciotat
Cedex, France. F
REASON Surgical camera
control units were not designed and manufactured to pass the IEC 60101 testing
for electrical fast transients (EFT)
VOLUME OF PRODUCT IN
COMMERCE 102
units
DISTRIBUTION Internationally
WEEK ENDING MAY 19
PRODUCT GE
Healthcare Engstrom Carestation Critical Care Ventilator with the High
Performance Display Unit with software version 3.x and 4.11;
identification numbers 1505-9000-000 and M1057699 (upgrade),
CODE
Serial numbers: CBCH00101, CBCH00110,
CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686,
CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru
CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru
CBCK00526, CBCK00535
RECALLING FIRM/MANUFACTURER Datex
– Ohmeda, Inc, Madison, WI,
REASON There are two unique conditions with
the Engstrom Carestation that require corrective action. These include an
anomaly in the control of the safety relief valve and a situation where the
display unit may reset.
VOLUME OF PRODUCT IN COMMERCE 449
units
DISTRIBUTION GA, RI, WI, and
TX
PRODUCT CIBASoft® Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50,
Diameter 13.8, Base Curve, 8.9, Expiration 2011-10,
CODE Lot #41074100201110
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corporation,
Duluth, GA,
Manufacturer: Ciba Vision Puerto Rico, Inc,
Cidra, PR.
REASON Base curve of
the lenses does not meet specification.
VOLUME OF PRODUCT IN
COMMERCE 22
lenses
DISTRIBUTION Nationwide
PRODUCT Gynecare
PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland,
CODE
Lot Number 2990052 2007-12
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Ethicon, Inc, Somerville, NJ,
Manufacturer: Ethicon
SARL, Neuchatel, Switzerland.
REASON The pre-printed outer
box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor
System (Product Code PFRT01). The contents of the box actually contain GYNECARE
PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
VOLUME OF
PRODUCT IN COMMERCE 60
units
DISTRIBUTION Nationwide
PRODUCT
a)
Maxi Move Patient Lift with Scale; Model KMBB4ELU2FUS,
b) Maxi Move Patient Lift with Scale; Model KMBB4MSU2FUS,
c) Maxi Move Patient Lift with Scale; Model KMBB4OLU2FUS,
d) Maxi Move Patient Lift with Scale; Model
KMBB4OSU2FUS,
CODE
a) Serial
numbers: SEE0624509, SEE0624510, SEE0624511, SEE0624512, SEE0624513,
SEE0624514, SEE0624515;
b) Serial numbers: SEE0628311, SEE0628312, SEE0628314, SEE0628315, SEE0628319, SEE0628320, SEE0628322, SEE0628323, SEE0628324, SEE0628326;
c) Serial numbers: SEE0624160, SEE0624161, SEE0624162, SEE0624163, SEE0624164, SEE0624165, SEE0624166, SEE0624167, SEE0624168, SEE0624169, SEE0624170, SEE0624171, SEE0624172, SEE0624173, SEE0624174, SEE0624175, SEE0624177, SEE0624178, SEE0624179, SEE0624180, SEE0624181, SEE0624182, SEE0624183, SEE0624184, SEE0624185, SEE0624186, SEE0624187, SEE0624188, SEE0624189, SEE0624190, SEE0624191, SEE0624192, SEE0624193, SEE0624194, SEE0624195, SEE0624196, SEE0624197, SEE0624198, SEE0624199, SEE0624200, SEE0624201, SEE0624202, SEE0624203, SEE0624204, SEE0624205, SEE0624206, SEE0624207, SEE0624208, SEE0624209, SEE0624210, SEE0624211, SEE0624212, SEE0624213, SEE0624214, SEE0624215, SEE0624216, SEE0624217, SEE0624218, SEE0624219, SEE0624220, SEE0624221, SEE0624222, SEE0624223, SEE0624224, SEE0624225, SEE0624226, SEE0624227, SEE0624228, SEE0624229, SEE0624230, SEE0624231, SEE0624233, SEE0624234, SEE0624235, SEE0624236, SEE0624237, SEE0624238, SEE0624239, SEE0624240, SEE0624567, SEE0624568, SEE0624569, SEE0624570, SEE0624571, SEE0624572, SEE0624573, SEE0624574, SEE0624575, SEE0624576, SEE0624577, SEE0624578, SEE0624579, SEE0624580, SEE0624581, SEE0624582, SEE0624583, SEE0624584, SEE0624585, SEE0624586, SEE0624587, SEE0624588, SEE0624589, SEE0624591, SEE0624592, SEE0624593, SEE0624594, SEE0624595, SEE0624596, SEE0624597, SEE0624598, SEE0624599, SEE0624600, SEE0624601, SEE0624602, SEE0624603, SEE0624604, SEE0624605, SEE0624606, SEE0624607, SEE0624608, SEE0624609, SEE0624610, SEE0624611, SEE0624612, SEE0624613, SEE0624614, SEE0624615, SEE0624616, SEE0624617, SEE0624618, SEE0624619, SEE0624621, SEE0624622, SEE0624623, SEE0624624, SEE0624625, SEE0624626, SEE0624628, SEE0624629, SEE0624630, SEE0624631, SEE0624632, SEE0624633, SEE0624634, SEE0624635, SEE0624636;
d) Serial numbers: SEE0627469, SEE0627470, SEE0627471, SEE0627472,
SEE0627473, SEE0627474, SEE0627476, SEE0627477, SEE0627478, SEE0627480,
SEE0627481, SEE0627482, SEE0627483, SEE0627484, SEE0627485, SEE0627486,
SEE0627487, SEE0627488, SEE0627489, SEE0627490, SEE0627491, SEE0627492,
SEE0627493, SEE0627494, SEE0627495, SEE0627496, SEE0627498, SEE0627499,
SEE0627500, SEE0627501, SEE0627502, SEE0627503, SEE0627504, SEE0627505,
SEE0627506, SEE0627507, SEE0627508, SEE0627509, SEE0627510, SEE0627511,
SEE0627512, SEE0627513, SEE0627514, SEE0627515, SEE0627516, SEE0627517,
SEE0627518, SEE0627519, SEE0627520, SEE0627521, SEE0627522, SEE0627523,
SEE0627524, SEE0627526, SEE0627527, SEE0627528, SEE0627529, SEE0627530,
SEE0627531, SEE0627532, SEE0627533, SEE0627534, SEE0627535, SEE0627536,
SEE0627537, SEE0627538, SEE0627539, SEE0627540, SEE0627541, SEE0627542,
SEE0627543, SEE0627544, SEE0628342, SEE0628343, SEE0628344, SEE0628345,
SEE0628346, SEE0628347, SEE0628348, SEE0628349, SEE0628350, SEE0628351,
SEE0628352, SEE0628353, SEE0628354, SEE0628355, SEE0628356, SEE0628357,
SEE0628358, SEE0628359, SEE0628360, SEE0628361, SEE0628362, SEE0628363,
SEE0628364, SEE0628365, SEE0628366, SEE0628367, SEE0628368, SEE0628369,
SEE0628370, SEE0628371, SEE0628372, SEE0628373, SEE0628374, SEE0628375,
SEE0628376, SEE0628377, SEE0628378, SEE0628379, SEE0628381, SEE0628382,
SEE0628383, SEE0628386, SEE0628388, SEE0628391, SEE0628399, SEE0628401,
SEE0628402, SEE0628403, SEE0628404
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc, Roselle, IL,
Manufacturer: Arjo Hospital Equipment,
Esloev, Sweden.
REASON The hanger bar assembly may detach from
the Maxi Move lifters with scale, due to an incorrect torque setting on the two
bolts holding the scale in place.
VOLUME OF PRODUCT IN
COMMERCE 284
lifts
DISTRIBUTION Nationwide
PRODUCT 3M
ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, is a
radiopaque , color stable light-cured resin cement indicated for bonding veneers
fabricated of porcelainor composite,
CODE Lot 20070124 on box/bag, 7CG code on syringe
RECALLING FIRM/MANUFACTURER 3M Espe Dental Products,
Irvine, CA,
REASON Cement in 3M ESPE RelyX Veneer
Cement Refill A3 Shade syringes, may not cure to the degree
expected.
VOLUME OF PRODUCT IN COMMERCE 99
units
DISTRIBUTION IN, PA, NY, CA, NV, AZ, and Malaysia
PRODUCT Boston Scientific
Medi-Tech Stainless Steel Greenfield Vena Cava Filter,
order #50-400, 7
CODE Lot #7826572
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific, Maple Grove, MN,
Manufacturer: Boston Scientific Cork, Ltd, Cork, Ireland.
REASON
One lot of
product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect
expiration date of 2008-07 and the correct date is 2008-06.
VOLUME
OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION Nationwide
PRODUCT Biohorizons
3 0mm Overdenture Implant System, REF 30120S2, (3 mm x 12 mm-2mm collar),
CODE
Lot: S0207053
RECALLING FIRM/MANUFACTURER BioHorizons Implant
Systems, Inc, Birmingham, AL,
REASON Dental implant system is
missing ball attachment system.
VOLUME OF PRODUCT IN
COMMERCE 34 units
DISTRIBUTION Nationwide and
Italy
WEEK ENDING MAY 26
PRODUCT
a)
GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System,
b) GE
LightSpeed VCT Select / LightSpeed Pro32, Model 5126093,
CT Scanner system,
c) GE LightSpeed Pro 16 (100kW/80kW)
Models 2357739, 2357739-3,
2357739-4, 2357739-6,
2357739-7 and 2357739-8, CT Scanner systems,
d) GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model
2374681-6,
CT Scanner systems,
e) GE Discovery
VCT, Volume PET-CT scanner, Model 5124069-3,
CODE All
serial numbers
RECALLING FIRM/MANUFACTURER General
Electric Med Systems, LLC, Waukesha, WI
REASON Oil may leak onto the port window of the
CT tube and may result in image artifacts that could lead to
misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 1,817
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT Roche
PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e
411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers;
catalog no. 11972103122,
CODE Lots
17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07;
17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and
17450903, exp. 5/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
Manufacturer:
Roche Diagnostics Gmbh,
Mannheim, Germany.
REASON Negative bias caused by hemolysis
interference at the low end of the reference range could cause erroneous
diagnosis of hypoparathyroidism.
VOLUME OF PRODUCT IN
COMMERCE 14,503
systems
DISTRIBUTION Nationwide
PRODUCT STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro
diagnostic analyzer,
CODE All units
with the last 4 digits of the serial number under 3450. Serial numbers 5050012
6060290 6070319 6070346 6090389 6090416 6090417 6090418 6100419 7010600 7010601
7010602 7010603 7010604 7010605 7010606 7010607 7010608 7010609 7010611 7010612
7020648 7020649 7020650 7020651 7020652 7020653 7020654 7020655 7020656 7020683
7020684 7020685 7020686 7020687 7030745 7030746 7030747 7030748 7030749 7030751
7030752 7040808 7040809 7040810 7040811 7040812 7040813 7040814 7040815 7040816
7040817 7050834 7050835 7050836 7050837 7050838 7050871 7050872 7050873 7050874
7050875 7050876 7050877 7050878 7050879 7060931 7060932 7060933 7060935 7060936
7060937 7060938 7060939 7060940 7091037 7091038 7091039 7091040 7091041 7091060
7091079 7091080 7091081 7121199 7121200 7121201 7121202 7121203 8011222 8011223
8011224 8011225 8011226 8011228 8011229 8011230 8011231 8021232 8021233 8021234
8021235 8021236 8021237 8021238 8021239 8021240 8021241 8021242 8021243 8021244
8021245 8021246 8021247 8021248 8021249 8021250 8021251 8031259 8031260 8031261
8031262 8031263 8031264 8031265 8031269 8031286 8031287 8031288 8031289 8031290
8041304 8041305 8041306 8041307 8041308 8041309 8041310 8041312 8041313 8041314
8041315 8041316 8041317 8041318 8061357 8061358 8071387 8071388 8071389 8071390
8071391 8071392 8071393 8071394 9011495 9011496 9011497 9011498 9011499 9011500
9011501 9021521 9021524 9021525 9021526 9021528 9021529 9021530 9021531 9021532
9021537 9021538 9021539 9021540 9031557 9031558 9031559 9041594 9041595 9041596
9041597 9041598 9041599 9051600 9051601 9051602 9051603 9051604 9061645 9061646
9061647 9061648 9061659 9061660 9061661 9061662 9061663 9071689 9071690 9071691
9071693 9071694 9071695 9071696 9071700 9081714 9081715 9081729 9081730 9081731
9081736 9081737 9091739 9091741 9091768 9091769 9091770 9091774 9091775 9091776
9091777 9091778 9091779 9091783 9091784 9091785 9091786 9091787 9101842 9101843
9101844 9101845 9101846 9101847 9101848 9101856 9111858 9111861 9111862 9111863
9111864 9111865 9111866 9111867 9111868 9111874 9111876 9111877 9111878 9111879
9111880 9111881 9111882 9111906 9111907 9111908 9111909 9111910 9111913 9111914
9111916 9111917 9111918 9111919 9111920 9121937 9121939 9121940 9121942 9121943
9121945 9121948 9121949 9121950 9121951 11971 11972 11973 11974 11975 11976
11977 11991 11992 11993 11994 11995 11996 11997 11998 21999 22000 22003 22008
22009 22010 22014 22015 22016 22017 22018 22019 22023 32036 32037 32038 32039
32040 32041 32042 32061 32062 32063 32064 32065 32071 32073 32074 32083 42109
42110 42111 42112 52141 52142 72239 72240 72241 82250 82251 82254 82255 82256
82257 82258 82259 82266 82267 82268 92269 92277 92278 92280 92281 92283 92288
92289 92290 92291 92293 92294 102299 102301 102302 102303 102304 102328 102331
102333 102334 102335 102336 102338 102339 102340 102342 102344 102345 102346
112350 112351 112352 112353 112354 112355 112356 112357 112368 112371 112372
112379 112380 112381 112382 112383 112384 112385 112386 112387 112388 122423
122424 122425 122427 122428 122429 122430 122431 122432 122433 1012434 1012435
1012456 1012457 1012458 1012460 1012461 1012462 1012463 1012465 1012474 1012475
1012476 1022502 1022513 1022514 1022515 1022516 1022517 1022518 1022520 1022521
1032523 1032524 1032527 1032528 1042578 1042579 1042580 1042581 1042582 1042583
1042584 1042585 1042586 1042587 1042588 1042589 1042590 1042591 1052634 1052635
1052636 1052637 1052638 1052639 1052640 1052641 1052642 1052643 1052645 1052647
1062676 10626771062678 1062683 1062684 1062685 1062686 1062687 1062688 1062689
1062690 1062691 1062692 1062693 1062694 1062696 1062697 1062699 1062700 1062702
1062703 1062704 1062705 1062706 1072751 1072752 1072753 1072754 1072755 1072757
1072758 1072759 1072766 1072767 1072768 1072769 1072770 1092815 1092816 1092817
1092818 1092819 1092820 1092821 1092822 1092823 1092824 1092825 1092826 1092827
1092828 1092830 1092831 1092832 1092833 1092834 1092836 1092848 1092849 1092850
1092851 1092852 1092853 1092854 1092855 1092856 1092857 1092858 1092861 1092862
1102869 1102871 1102873 1102874 1102875 1102876 1102877 1102895 1102911 1112927
1112949 1112950 1112951 1112952 1112953 1112954 1112955 1112956 1112957 1112958
1112959 1112960 1112961 1112962 1123008 1123009 1123011 1123013 1123014 1123015
1123016 2013050 2013051 2013052 2023108 2023109 2023110 2023111 2023112 2023113
2023114 2023115 2023116 2023117 2023118 2023121 2023122 2023123 2023124 2023125
2023126 2023127 2023128 2023129 2023130 2023131 2023132 2023133 2023134 2023151
2023152 2023153 2023188 2023189 2023190 2023191 2023192 2033193 2033194 2033195
2033196 2033197 2033198 2033199 2033200 2033201 2033202 2033203 2043224 2043225
2043226 2043227 2043228 2043229 2043230 2043231 2043232 2043233 2043234 2043237
2043238 2043239 2043240 2043241 2043242 2043243 2043244 2043245 2043251 2043252
2043253 2043254 2043255 2043256 2043257 2043258 2043259 2043260 2043266 2043268
2043269 2043271 2043272 2043288 2043289 2043291 2043292 2043293 2043295 2043296
2043297 2053299 2053300 2053301 2053302 2053303 2053304 2053305 2053346 2053348
2053349 2053350 2053351 2053352 2053353 2053354 2053355 2053356 2053357 2053358
2053359 2053360 2053361 2053362 2063364 2063365 2063366 2063367 2063368 2073397
2073398 2073399 2073400 2073401 2073402 2073404 2073405 2073406 2073418 2073419
2073420 2073421 2073422 2073423 2073424 2073425 2073446 2073447 2073448
2073449
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Diagnostica Stago, Inc., Parsippany, NJ,
Manufacturer: Diagnostica
Stago, Franconville, France.
REASON Result of complaints of field failures of
the silicon bridge rectifier, resulting in smoke billowing out of the unit and
burnt circuit boards, wires and connectors.
VOLUME OF PRODUCT IN
COMMERCE 693
units
DISTRIBUTION Nationwide
PRODUCT BacT/VIEW®
Software, all versions. in vitro diagnostic database software,
CODE
Software Version C.30a -22105-68, Update
Disk; 22105-69 Install Disk
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc, Durham, NC
REASON BacT/VIEW will be unable to run scheduled
macro applications unless the user touches the BacT/VIEW touch screen or clicks
a function after resynchronizing the clocks.
VOLUME OF PRODUCT IN
COMMERCE 1233 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT GE
Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System,
CODE
00000249264MR3, 00000257756MR7,
00000255196MR8, 00000246630MR8, 00000259107MR1, 00000248178MR6, 00000257451MR5,
00000256200MR7, 00000260871MR9, 00000252451MR0, 00000259108MR9, 00000254480MR7,
00000254482MR3, 00000256198MR3, 00000249263MR5, 00000250755MR6, 00000251090MR7,
00000GE0131001, 00000GE0213040, 00000254375MR9, 00000GE0205028, 00000GE0210034,
00000227995MR8, 00000GE0212037, 00000GE0226049, 00000GE0410083, 00000260871MR9,
00000GE0234057, 00000GE0123041, 00000GE0302068
RECALLING
FIRM/MANUFACTURER GE Medical Systems LLC, Waukesha, WI,
REASON
To provide the 3.0T MRI systems users
with the 8-channel brain coil the proper coil weighting software. The proper
coil weighting factors for the eight-channel brain coil were not included in the
software.
VOLUME OF PRODUCT IN COMMERCE 30
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Cranex
Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging,
CODE
Serial numbers X51146, X51147,
X51148, X51154, X51155, X51156, X51170, X51171, X61188
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Instrumentarium Dental,
Inc, Milwaukee, WI,
Manufacturer:
Soredex Palodex Group Oy, Tuusula, Finland.
REASON
There may be a material defect in the
up/down movement axle of the unit. This may cause the upper part of the unit to
suddenly come down.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model
numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36, CODE Lot numbers: 593025-5, 593027-5,
598408-5, 593028-5, 599866-5 and 593029-5
RECALLING
FIRM/MANUFACTURER Biomet 3i, Palm Beach Gardens, FL,
REASON
The Straight Healing Abutment did not
fully seat to the restorative platform of the implant, leaving a gap between the
abutment and the implant.
VOLUME OF PRODUCT IN
COMMERCE 362 units
DISTRIBUTION Nationwide
and Internationally