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U.S. Department of Health and Human Services

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Enforcement Report for February 18, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

February 18, 2009
09-07

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
___________________________________ 
PRODUCT 
APS Ursodiol Capsules USP 300 mg, NDC 51079-097-20 Dose NCD 51079-097-01. Recall # D-181-2009
CODE 
Lot #072890 Exp Date 11/08; Lot #073356 Exp Date 11/08; Lot #073995 Exp Date 02/09; Lot #074202 Exp Date 02/09
RECALLING FIRM/MANUFACTURER 
Recalling Firm: American Health Packaging, Columbus , OH , by letters on August 6, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON 
GMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE 
184 amber bags of 100 capsules
DISTRIBUTION 
GA, PA and TX
___________________________________ 
PRODUCT 
a) Phentermine Hydrochloride Capsules, 15 mg, packaged in blister packs of 14 and 28 and bottles of 30 and 60, Schedule IV, Rx only. a) Product number: 4143-0 (28 capsules); b) Product number: 4143-2 (14 capsules); c) Product number: 4143-4 (30 capsules); d) Product number 4143-5 (60 capsules). Recall # D-183-2009;
 
b) Phentermine Hydrochloride Capsules, 37.5 mg, packaged in blister packs of 28 and bottles of 30, Schedule IV, Rx only. a) Product number: 4816-1 (30 capsules); b) Product number 4816-2 (28 capsules). Recall # D-184-2009;
 
c) Phentermine Hydrochloride Tablets, 37.5 mg, packaged in blister packs of 7, 14 and 28 and bottles of 30, 45, 60 and 100, Schedule IV, Rx only. a) Product number: 3203-0 (30 tablets); b) Product number: 3203-1 (14 tablets); c) Product number: 3203-2 (7 tablets), d) Product number: 3203-3 (60 tablets); e) Product number: 3203-4 (45 tablets); f) Product number: 3203-8 (28 tablets); g) Product number: 5224-2 (100 tablets). Recall # D-185-2009;
 
d) Phenazopyridine Tablets, 100 mg, packaged in blister packs of 10, Rx only. Product number: 0199-0 (10 tablets. Recall # D-186-2009;
 
e) Hyoscyamine Sulfate Tablets 0.125 mg packaged in blister packs of 20, Rx only. Product number: 3763-2 (20 tablets). Recall # D-187-2009;
 
f) Prenatal Plus w/27 mg Iron Tablets, Multivitamin/multimineral supplement, packaged in bottles of 30, Rx only. Product number: 4552-1 (30 tablets). Recall # D-188-2009;
 
g) Sodium Fluoride Chewable Tablets, 1.1 mg, equivalent to 0.5 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2870-1 (100 tablets). Recall # D-189-2009;
 
h) Sodium Fluoride Chewable Tablets, 2.2 mg, equivalent to 1.0 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2871-1 (100 tablets). Recall # D-190-2009;
 
i) Cyclobenzaprine HCL Tablets, 5 mg, packaged in bottles of 30, Rx only. Product number: 5782-0 (30 tablets). Recall # D-191-2009;
 
j) Trimethobenzamide HCL Capsules, 300 mg, packaged in blister packs of 6 and 12, Rx only. a) Product number: 5589-0 (12 capsules); b) Product number: 5589-1 (6 capsules). Recall # D-192-2009;
 
k) Tizanidine HCL Tablets, 2 mg, packaged in bottles of 30, Rx only. Product number: 5443-0 (30 tablets). Recall # D-193-2009;
 
l) Tizanidine HCL Tablets, 4 mg, packaged in bottles of 15, 30, 60 and 120, Rx only.
a) Product number: 5500-0 (120 tablets); b) Product number: 5500-2 (60 tablets); c) Product number 5500-3 (15 tablets); d) Product number 5500-4 (30 tablets). Recall # D-194-2009
CODE 
a) a) Lot numbers: 6353294, 7046061, 7064197, 7064227, 7086179, 7176189, 7218310, 7261156 and 8028255; b) lot numbers: 6362168, 7064198, 7156173, 7186021 and 7299072; c) lot numbers: 6285188, 6326161, 7046009, 7052150, 7142221, 7200019, 7274235, 7306094, 7351190, 7254042, 8077139 and 8127175; d) lot numbers: 6356076, 7046008, 7142222, 7166063, 7176190 and 7200018;
 
b) a) Lot numbers: 7052149, 7086178, 7141205, 7200016, 7339221, 7347066, 8052097 and 8137081; b) lot numbers: 7150130, 7227122, 7309215, 8023140 and 8081124;
 
c) a) Lot numbers: 6248181, 6270214, 6297240, 8321028, 6326160, 6347195, 6362172, 7036225, 7036226, 7036227, 7047031, 7050173, 7053032, 7064196, 7071230, 7086175, 7089079, 7107172, 7117045, 7127197, 7135185, 7143113, 7145036, 7145037, 7176181, 7200020, 7200021, 7207018, 7242022, 7242023, 7268184, 7289212, 7292061, 7306092, 7306093, 7313032, 7324225, 7352208, 7360034, 8002001, 8003057, 8025072, 8032115, 8028234, 8044104, 8051106, 8060101, 8067026, 8067027, 8074096, 8081120, 8088070, 8102062, 8102063, 8112202, 8130093, 8135092, 8134131 and 8134152; b) lot numbers: 6297241, 7030207, 7036224, 7036228, 7045139, 7050217, 7086177, 7135186, 7144018, 7288173, 7365192, 7354041, 8081121 and 8133154; c) lot numbers: 7945143, 7050186, 7059197, 7107171, 7130065, 7143115, 7268183, 8023120, 8081122 and 8087021; d) lot numbers: 6270215, 6282199, 6321027, 6333012, 7003117, 7127198, 7141220, 7227121, 7317179, 8095101 and 8107099; e) lot numbers: 6258012, 6284181, 7047032, 7086176, 7120122, 7134221, 7136127, 7176182, 8024089, 8043204, 8052118, 8074105 and 8130095; f) lot numbers: 6270265, 6296189, 6362136, 7071231, 7129142, 7152044, 7220125, 7285100, 8039081 and 8123107; g) lot numbers: 7274226, 7344209, 8009151, 8023119, 8031105, 8084156 and 8130094;
 
d) Lot number: 7254195;
 
e) Lot numbers: 6040156, 6303249, 6348264, 7124111 and 7149170;
 
f) Lot numbers: 6230072, 6335058, 7075075, 7186040, 7241170 and 7250053;
 
g) Lot numbers: 6018214, 6100189, 6103128, 6128153, 6156190, 6160024, 7138051, 7163136, 7214015, 7234134, 7241180 and 8150026;
 
h) Lot numbers: 5319231, 6100190 and 6128154;
 
i) Lot numbers: 7099219, 7135183, 7151061, 7171121, 7183269, 7239200, 7260240, 7310156, 7310157, 8010045, 8102078 and 8189189;
 
j) a) Lot numbers: 6313276, 7038210, 7130107, 7201041, 7306089, 7316239, 8067051 and 8107154; b) lot numbers: 7123003, 7243036, 7268170, 7306090 and 8050216;
 
k) Lot numbers: 6304073, 6313206, 6340179, 6348178, 7002214, 7005057, 7067082, 7075030 and 7092179;
 
l) a) Lot numbers: 6321049, 7024146, 7025068, 7032066, 7250041 and 7271095;
b) lot numbers: 6286118, 7038209, 7064207, 7064208, 7073180, 7085158, 7093155, 7096091, 7115108, 7115109, 7123070, 7130092, 7135192, 7215064, 7242047, 7271066 and 7271094; c) lot numbers: 6313195, 7053065, 7096092 and 7130091; d) lot numbers: 6293054, 6321079, 7033052, 7085185, 7093171, 7096073, 7114144 and 7138034
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Allscripts, Libertyville , IL , by letters on July 1, 2008, July 2, 2008, July 11, 2008, July 14, 2008, August 1, and August 4, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON 
Multiple cGMP deviations and stability failures found at the manufacturer, Actavis Totowa LLC.
VOLUME OF PRODUCT IN COMMERCE 
655,418 capsules, 5,629,312 tablets
DISTRIBUTION 
Nationwide
  
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0464-09;
b) Recovered Plasma. Recall # B-0465-09
CODE 
a) and b) Unit: S93413
RECALLING FIRM/MANUFACTURER 
Central Illinois Community Blood Center , Springfield , IL , by facsimile or e-mail on August 5, 2008 and by letter dated August 5, 2008. Firm initiated recall is complete.
REASON 
Blood products, which were incorrectly tested for Hepatitis B surface antigen (HBsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
IL, RI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0475-09
CODE 
Unit: W036908304113
RECALLING FIRM/MANUFACTURER 
Blood Bank of Delmarva, Inc, Newark , DE , by telephone on July 18, 2008 and follow up letter dated August 18, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0477-09
CODE 
Unit: 9621879
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers , Baton Rouge , LA , by telephone and electronic mail beginning on November 13, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
LA
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0479-09
CODE 
Unit: 9622103
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers , Baton Rouge , LA , by telephone and electronic mail beginning on November 13, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
LA
___________________________________ 
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-0481-09
CODE 
Unit: 242477389
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone and facsimile on May 31, 2006.
Manufacturer: Blood Systems, Inc., Rapid City , SD. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
NH
___________________________________ 
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0482-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0483-09
CODE 
a) and b) Unit: GJ02318
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by fax on August 10, 2006. Firm initiated recall is complete.
REASON 
Blood products, labeled leukoreduced which did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
WI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0489-09
CODE 
Unit: LE84191
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by fax on March 9, 2006. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who may have received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
WI
___________________________________ 
PRODUCT 
Red Blood Cells, Recall # B-0490-09
CODE 
Unit: Q06131
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter on June 18, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AR
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0494-09
CODE 
Units: 363021183, 363021054, 363019176, 363018779, 363017328, 363017151, 363016461, 363016195, 363015655, 363015074, 363014505, 363014144, 363013332, 363011329, 363009566
RECALLING FIRM/MANUFACTURER 
Talecris Plasma Resources, Inc., Fort Worth , TX , by fax on August 17, 2006. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
15 units
DISTRIBUTION 
NC
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0497-09
CODE 
Unit: 72H908112
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc, Dunwoody , GA , by telephone on November 17, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
GA
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0498-09
CODE 
Unit: 72H554502
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc, Dunwoody , GA , by telephone on September 3, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
GA
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0499-09
CODE 
Unit: 72H36237X
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc, Dunwoody , GA , by telephone on September 16, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
GA
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0500-09
CODE 
Unit: 72H345962
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc, Dunwoody , GA , by telephone on August 21, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
GA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0466-09;
b) Recovered Plasma. Recall # B-0467-09
CODE 
a) and b) Unit: S96652
RECALLING FIRM/MANUFACTURER 
Central Illinois Community Blood Center , Springfield , IL , by facsimile or e-mail on August 5, 2008 and by letter dated August 5, 2008. Firm initiated recall is complete.
REASON 
Blood products, which were incorrectly tested for Hepatitis B surface antigen (HBsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
IL, RI
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0476-09
CODE 
Unit: 9621879
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers , Baton Rouge , LA , by telephone and electronic mail beginning on November 13, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
Switzerland
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0478-09
CODE 
Unit: 9622103
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers , Baton Rouge , LA , by telephone and electronic mail beginning on November 13, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
Switzerland
___________________________________ 
PRODUCT 
Fresh Frozen Plasma, Recall # B-0495-09
CODE 
Unit: KF16045
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by fax on April 7, 2006. Firm initiated recall is complete.
REASON 
Blood product, possible exposed to unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
WI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0496-09
CODE 
Unit: FS14374
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by fax on March 9, 2006. Firm initiated recall is complete.
REASON 
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
NJ
___________________________________ 
PRODUCT 
Platelets, Recall # B-0480-09
CODE 
Unit: 7968711
RECALLING FIRM/MANUFACTURER 
Carter BloodCare, Bedford , TX , by telephone on August 23, 2007 and follow up letter dated August 30, 2007. Firm initiated recall is complete.
REASON 
Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TX
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. Recall # Z-0863-2009
CODE 
Serial numbers: PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000
RECALLING FIRM/MANUFACTURER 
Sunrise Medical, Somerset , PA , by telephone on October 27, 2008 and by letter on November 3, 2008. Firm initiated recall is ongoing.
REASON 
Improper suction: Regulator knob does not turn properly which can affect the suction level.
VOLUME OF PRODUCT IN COMMERCE 
78 units
DISTRIBUTION 
Nationwide and countries of Mexico , Guatemala , Columbia , and Costa Rica
___________________________________ 
PRODUCT 
SERVO Ventilator 300A (SV300A). The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market. Recall # Z-0872-2009
CODE 
All units of SV300A
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Maquet, Inc., Bridgewater , NJ , by letters on December 22, 2008.
Manufacturer: Maquet Critical Care AB , Solna , Sweden . Firm initiated recall is ongoing.
REASON 
SERVO Ventilator 300A could cause hyperventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
VOLUME OF PRODUCT IN COMMERCE 
3,688 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) Zimmer TIV Self Tap Screw, 40 mm. Item number: 48231904000. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. Recall # Z-904-2009;
 
b) Zimmer TIV Self Tap Screw, 42 mm. Item number: 48231904200. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. Recall # Z-905-2009
CODE 
a) Lot number: 60557215;
b) Lot numbers: 60548987, 60548986, 60548999, 60557220 and 60557219
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Zimmer, Inc., Warsaw , IN , by letter dated December 11, 2008.
Manufacturer: Zimmer Manufacturing B.V., Mercedita, PR. Firm initiated recall is ongoing.
REASON 
The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
VOLUME OF PRODUCT IN COMMERCE 
508 units
DISTRIBUTION 
Japan
___________________________________ 
PRODUCT 
a) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6647, a) inner pouch UPN M00566470 and b) outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0911-2009;
 
b) Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6649, a) inner pouch UPN M00566490 and b) outer carton UPN M00566491. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0912-2009;
 
c) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6653, a) inner pouch UPN M00566530 and b) outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0913-2009;
 
d) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6673, a) inner pouch UPN M00566730 and b) outer carton UPN M00566731. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0914-2009
CODE 
a) a) Lot numbers: 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831; b) lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424;
 
b) a) Lot numbers: 12007899 and b) lot numbers: 12065904 and 12148450;
 
c) Lot number: 12080466 on both pouches;
 
d) a) Lot numbers: 12015222, 12015223, 12017140, 12035930, 12037032, 12038621, 12056814, 12074992, 12096466, 12110667, 12111382, 12111566, 12112012, 12113348, 12129137, 12133028, 12133803 and 12133804; b) lot numbers: 12065719, 12065900, 12065903, 12088673, 12105251, 12115743, 12119946, 12145423 and 12148447
RECALLING FIRM/MANUFACTURER 
Boston Scientific, Corp., Spencer , IN , by letter dated December 30, 2008.
Firm initiated recall is ongoing.
REASON 
The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
VOLUME OF PRODUCT IN COMMERCE 
2,460 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-025, REF 500-166-25. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0923-2009;
 
b) Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-050, REF 500-166-50. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0924-2009;
 
c) Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Product number: 0500-200-000, REF 500-200. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0925-2009
CODE 
a) Lot number: 2008011403, 2008020502, 2008061701 and 2008072102;
b) Lot number: 2008011404 and 2008050201;
c) Lot number: 2008011601, 2008040204 and 2008061801;
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Portage , MI , by letter dated November 11, 2008.
Manufacturer: Medisize Donegal Healthcare, Donegal , Ireland . Firm initiated recall is ongoing.
REASON 
There is a potential for the pump to overinfuse.
VOLUME OF PRODUCT IN COMMERCE 
118 boxes
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. REF 575-100, Product Number 0575-100-000. The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management; the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous. Recall # Z-0926-2009
CODE 
Lot numbers: 08219012, 08220012, 08221012, 08222012, 08225012, 08226012, 08229012, 08231022, 08233012, 08234012, 08235012, 08238022, 08239012, 08241012, 08242012, 08243012, 08246022, 08247012, 08249032, 08250012, 08252022, 08252032, 08253012, 08254012, 08256032, 08256042, 08257012 and 08259022
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Instruments, Div. of Stryker Corp., Portage , MI , by letter dated November 12, 2008.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON 
The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.
VOLUME OF PRODUCT IN COMMERCE 
2,009 boxes
DISTRIBUTION 
Nationwide and Canada
___________________________________ 
PRODUCT 
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Part Number 8139789. Recall # Z-0927-2009
CODE 
Serial numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425
RECALLING FIRM/MANUFACTURER 
Siemens Medical Solutions USA, Inc., Concord , CA , by letter dated October 23, 2008. Firm initiated recall is ongoing.
REASON 
If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstances.
VOLUME OF PRODUCT IN COMMERCE 
36 units
DISTRIBUTION 
Nationwide and countries of Netherlands , Germany , Poland , Norway , Australia , Hungary , Belgium , New Zealand , France , Malaysia , Spain and Canada
___________________________________ 
PRODUCT 
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0928-2009
CODE 
Software version 2.1.5.5 and 3.0.4 and higher
RECALLING FIRM/MANUFACTURER 
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 21, 2008. Firm initiated recall is ongoing.
REASON 
There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
VOLUME OF PRODUCT IN COMMERCE 
476 units
DISTRIBUTION 
Nationwide and Canada
___________________________________ 
PRODUCT 
Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft. Recall # Z-0931-2009
CODE 
Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Synthes Spine, West Chester , PA , by e-mail on November 20, 2008 and by letters dated November 19, 2008 and January 16, 2009.
Manufacturer: Synthes Gmbh, Oberdorf , Switzerland . Firm initiated recall is complete.
REASON 
Screwdriver tip may break off and lodge in the screw head.
VOLUME OF PRODUCT IN COMMERCE 
381 units
DISTRIBUTION 
Nationwide and countries of Canada and Switzerland
___________________________________ 
PRODUCT 
Ergolift 400 Lbs. Floor Lift, model/part numbers ERGOLIFT and ERGOLIFT-2. The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients. Recall # Z-0933-2009
CODE 
Serial numbers: ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Arjo, Inc., Roselle , IL , by Field Safety Notice dated December 8, 2008 and letter dated December 22, 2008.
Manufacturer: B.H.M. Medical, Inc., Magog , Canada . Firm initiated recall is ongoing.
REASON 
Report of structural failure of the mast during use.
VOLUME OF PRODUCT IN COMMERCE 
220 lifts
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Posey Connecting Straps and Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt. Catalog numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213. Recall # Z-0934-2009
CODE 
Unknown
RECALLING FIRM/MANUFACTURER 
J. T. Posey Company, Arcadia , CA , by letter dated August 15, 2008. Firm initiated recall is ongoing.
REASON 
A patient may be able to catch the belt on a stationary object and use their body force to tear or break the strap, creating freedom of arm movement.
VOLUME OF PRODUCT IN COMMERCE 
51,200 devices (approximately)
DISTRIBUTION 
Nationwide and countries of Australia , Belgium , Canada , France , Germany , Ireland , Italy , Korea , Lithuania and Netherlands
___________________________________ 
PRODUCT 
Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800.
Recall # Z-0936-2009
CODE 
Lot numbers: 056398 and 056399
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Spine, Allendale ,  NJ , by letters on September 8, 2006.
Manufacturer: Stryker Spine, Cestas, Aquitane , France . Firm initiated recall is complete.
REASON 
DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
VOLUME OF PRODUCT IN COMMERCE 
37 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-08. Recall # Z-0938-2009;
 
b) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-12, 8061961 and Part Number: 1011750-12. Recall # Z-0939-2009
CODE 
a) Lot numbers: 8050961 and 8062361;
b) Lot Numbers: 8041051, 8050561, Lot Number 8100761
RECALLING FIRM/MANUFACTURER 
Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula , CA , by letter dated November 6, 2008. Firm initiated recall is ongoing.
REASON 
The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the balloon during shipment. It is disposed of during device preparation.
VOLUME OF PRODUCT IN COMMERCE 
224 devices
DISTRIBUTION 
Nationwide and Internationally
___________________________________ 
PRODUCT 
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database. Equipment number: 15013696; Equipment number: 10281800; Equipment number: 10262174; Equipment number: 15003839; and Equipment number: 15009724. Recall # Z-0945-2009
CODE 
Serial number: KQRCPF9; Serial number: BQWBZ81; Serial number: FB5C561; Serial number: USE708NBP3 and Serial number: GN6Z1E1
RECALLING FIRM/MANUFACTURER 
AGFA Corp., Greenville , SC , by letter on/about December 24, 2008. Firm initiated recall is ongoing.
REASON 
Polling procedure may fail when multiple merge/split is carried out.
VOLUME OF PRODUCT IN COMMERCE 
5 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System. Recall # Z-0946-2009
CODE 
All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412. ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001
RECALLING FIRM/MANUFACTURER 
St Jude Medical, Inc., Sunnyvale , CA , by letter dated December 4, 2008. Firm initiated recall is ongoing.
REASON 
Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
VOLUME OF PRODUCT IN COMMERCE 
152 units
DISTRIBUTION 
Nationwide and country of Belgium
___________________________________ 
PRODUCT 
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Recall # Z-0948-2009
CODE 
Versions 4.1.x up to and including 4.1.51.3
RECALLING FIRM/MANUFACTURER 
Philips Healthcare Informatics, Inc., Foster City , CA , by letter on December 29, 2008. Firm initiated recall is ongoing.
REASON 
Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
VOLUME OF PRODUCT IN COMMERCE 
40 units
DISTRIBUTION 
Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, Brazil 
___________________________________ 

PRODUCT 
Artiste MV Digital Linear Accelerator System equipped with 160 MCL Accessory Holder. Medical charged-particle radiation therapy system. Recall # Z-0949-2009
CODE 
All units of Part number: 8139789
RECALLING FIRM/MANUFACTURER 
Siemens Medical Solutions USA, Inc., Concord , CA , by letters on December 20, 2008. Firm initiated recall is ongoing.
REASON 
The range of tolerance is too high for the accessory holder; therefore, Wedges and other accessories do not latch to the locking mechanism correctly. This issue represents a potential serious injury to a patient or operator.
VOLUME OF PRODUCT IN COMMERCE 
43 units
DISTRIBUTION 
Nationwide and Internationally
___________________________________ 
PRODUCT 
a) HR90K Platinum Series Headpiece Model Number AB-7300-001. The HiRes90K headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0956-2009;
 
b) Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0957-2009;
 
c) S-Series Long Range Headpiece a) Model Number AB-5301-00 (beige) and b) AB-5301-10 (brown). The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. Recall # Z-0958-2009;
 
d) S-Series Short Range Headpiece, a) Model Number MMT-5300-00 (beige) and b) MMT-5300-10 (brown). The headpiece is used in conjunction with speech processors. Recall # Z-0959-2009
CODE 
a) Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694;
 
b) Serial Numbers: 36241, 36242, 36243, 36244, 36245, 36246, 36247, 36248, 36249, 36250, 36251, 36252, 36253, 36254, 36255, 36256, 36257, 36258, 36259, 36260, 36261, 36262, 36263, 36264, 36265, 36266, 36267, 36268, 36269, 36270, 36271, 36272, 36273, 36274, 36275, 36276, 36291, 36292, 36293, 36295, 36297, 36298, 36299, 36300, 36324, 36325, 36326, 36327, 36328, 36329, 36330, 36331, 36332, 36333, 36334, 36335, 36336, 36338, 36339, 36340, 36341, 36342, 36343, 36344, 36345, 36346, 36347, 36348, 36349, 36350, 36351, 36352, 36353, 36354, 36355, 36356, 36357, 36358, 36359, 36360, 36481, 36482, 36483, 36484 36485, 36486, 36487, 36488, 36489, 36490, 36491, 36493, 36494, 36495, 36496, 36497, 36498, 36499, 36500, 36501, 36502, 36503, 36504, 36506, 36507, 36508, 36509, 36510, 36511, 36512, 36513, 36514, 36515 36516, 36517, 36518, 36519, 36520, 36521, 36522, 36523, 36524, 36525, 36526, 36527, 36528, 36529 36530, 36531, 36532, 36533, 36534, 36535, 36536, 36537, 36538, 36539, 36540, 36568, 36569, 36570, 36571, 36572, 36573, 36574, 36575, 36576, 36577, 36578, 36579, 36580, 36581, 36582, 36583 36584, 36585, 36586, 36587, 36588, 36589, 36590, 36591, 36592, 36593, 36594, 36595, 36596, 36597, 36598, 36599, 36600, 36601, 36602, 36603, 36604, 36605, 36606, 36607, 36608, 36609, 36610, 36611, 36612, 36613, 36614, 36615, 36616, 36617, 36618 36620, 36621, 36622, 36623, 36624, 36625, 36626, 36627, 36628, 36629, 36630, 36631, 36632, 36633, 36634, 36635, 36636, 36637, 36638, 36639, 36640, 36641, 36642, 36643, 36644, 36645, 36646, 36647, 36648, 36649, 36650, 36651, 36652, 36653, 36654, 36655, 36656, 36657, 36658, 36659, 36660, 36661, 36662, 36663, 36664, 36665, 36666, 36667, 36668, 36669, 36670, 36671, 36672, 36673, 36674, 36675, 36676, 36677, 36678, 36679, 36680, 36718, 36719, 36720, 36721, 36722, 36723, 36724, 36725, 36726, 36727, 36728, 36729, 36731, 36732, 36733, 36735, 36736, 36737, 36738, 36739, 36740, 36742, 36743, 36744, 36745, 36746, 36751, 36752, 36755, 36756, 36757, 36758, 36759, 36760, 36761, 36762, 36763, 36764, 36765, 36766, 36767, 36769, 36770, 36771, 36772, 36773, 36774, 36775, 36776, 36777, 36778, 36779, 36780, 36781, 36782, 36784, 36785, 36786, 36787, 36789, 36790, 36791, 36792, 36793, 36794, 36795, 36796, 36797, 36798, 36799, 36800, 36801, 36802, 36803, 36804, 36805, 36806, 36807, 36808, 36809, 36810, 36811, 36812, 36813, 36814, 36815, 36816, 36817, 36818, 36819, 36820, 36821, 36822, 36823, 36824, 36825, 36827, 36828, 36829, 36830, 36831, 36832, 36833, 36834, 36835, 36836, 36837, 36838, 36839, 36840, 36841, 36842, 36843, 36844, 36845, 36846, 36847, 36848, 36849, 36850, 36851, 36852, 36853, 36854, 36855, 36856, 36857, 36858, 36859, 36860, 36868, 36892, 36893, 36895, 36898, 36900, 36901, 36902, 36904, 36905, 36906, 36907, 36908, 36909, 36910, 36921, 36922, 36923, 36924, 36925, 36926, 36927, 36928, 36929, 36931, 36932, 36933, 36934, 36935, 36936, 36937, 36938, 36939, 36940, 36941, 36942, 36943, 36944, 36945, 36946, 36947, 36948, 36949, 36950, 36952, 36965, 36966, 36968, 36971, 36972, 36973, 36975, 36976, 36977, 36979, 36981, 36982, 36983, 36985, 36986, 36987, 36989, 36990, 36991, 36992, 36993, 36994, 36995, 36996, 36997, 36999, 37000, 37001, 37002, 37003, 37004, 37005, 37006, 37007, 37008, 37009, 37010, 37041, 37042, 37043, 37044, 37045, 37046, 37047, 37048, 37049, 37050, 37051, 37052, 37053, 37054, 37055, 37056, 37057, 37058, 37059, 37060, 37061, 37062, 37063, 37064, 37065, 37066, 37068, 37069, 37101, 37102, 37103, 37104, 37105, 37106, 37107, 37108, 37109, 37110, 37111, 37112, 37113, 37114, 37131, 37132, 37133, 37134, 37135, 37136, 37138, 37139, 37140, 37141, 37142, 37143, 37144, 37145, 37146, 37147, 37148, 37149, 37150, 37151, 37152, 37153, 37154, 37155, 37156, 37158, 37159, 37160, 37177, 37178, 37180, 37181, 37182, 37184, 37185, 37190, 37191, 37192, 37193, 37194, 37195, 37196, 37197, 37198, 37199, 37200, 37206, 37207, 37208, 37209, 37210, 37211, 37212, 37213, 37214, 37215, 37216, 37217, 37218, 37219, 37228, 37236, 37242, 37245, 37247, 37251, 37252, 37253, 37254, 37255, 37257, 37258, 37259, 37260, 37261, 37262, 37263, 37264, 37265, 37266, 37268, 37269, 37270, 37271, 37273, 37274, 37277, 37279, 37284, 37288, 37290, 37293, 37295, 37296, 37297, 37298, 37299, 37300, 37302, 37304, 37308, 37310, 37323, 37324, 37325, 37326, 37327, 37328, 37329, 37330, 37331, 37332, 37333, 37334, 37335, 37336, 37337, 37338, 37339, 37340, 37341, 37342, 37343, 37344, 37345, 37346, 37347, 37348, 37349, 37350, 37351, 37353, 37354, 37356, 37357, 37358, 37359, 37360, 37361, 37362, 37363, 37364, 37365, 37366, 37367, 37368, 37369, 37373, 37378, 37380, 37381, 37382, 37383, 37384, 37385, 37386, 37387, 37388, 37389, 37390, 37391, 37392, 37393, 37394, 37395, 37396, 37397, 37398, 37401, 37404, 37406, 37413, 37430, 37431, 37432, 37434, 37437, 37438, 37439, 37440, 37441, 37442, 37443, 37444, 37445, 37446, 37447, 37448, 37449, 37450, 37451, 37452, 37453, 37454, 37455, 37456, 37457, 37458, 37459, 37460, 37461, 37462, 37463, 37464, 37465, 37466, 37467, 37468, 37469, 37470, 37471, 37472, 37473, 37474, 37475, 37479, 37480, 37481, 37482, 37483, 37484, 37488, 37490, 37493, 37496, 37497, 37498, 37501, 37502, 37503, 37504, 37505, 37506, 37507, 37508 37509, 37510, 37511, 37512, 37513, 37514, 37515, 37516, 37517, 37518, 37519, 37520, 37522, 37523, 37524, 37525, 37526, 37527, 37528, 37532, 37534, 37535, 37536, 37537, 37540, 37542, 37543, 37544, 37546, 37547, 37549, 37551, 37552, 37553, 37554, 37555, 37556, 37557, 37558, 37559, 37572, 37573, 37574, 37575, 37576, 37577, 37578, 37579, 37580, 37581, 37582, 37583, 37584, 37585, 37586, 37587, 37588, 37589, 37592 37600, 37615, 37616, 37620, 37621, 37622, 37626, 37630, 37632, 37633, 37634, 37636, 37638, 37639, 37640, 37641, 37642, 37643, 37644, 37645, 37646, 37647, 37648, 37649, 37650, 37651, 37652, 37655, 37658, 37659, 37663, 37664, 37665, 37667, 37670, 37671, 37672, 37673, 37674, 37676, 37677, 37678, 37679, 37681, 37682, 37683, 37684, 37685, 37686, 37687, 37688, 37689, 37690, 37691, 37692, 37693, 37694, 37695, 37696, 37697, 37698, 37699, 37700, 37701, 37702, 37703, 37704, 37705, 37706, 37707, 37708, 37709, 37710, 37711, 37712, 37715, 37716, 37717, 37718, 37719, 37720, 37721, 37723, 37724, 37726, 37727, 37728, 37729, 37730, 37731, 37732, 37733, 37734, 37735, 37736, 37737, 37738, 37739, 37740, 37741, 37742, 37743, 37744, 37745, 37746, 37747, 37748, 37749, 37750, 37751, 37752, 37753, 37754, 37755, 37756, 37757, 37758, 37760, 37761, 37763, 37764, 37765 37766, 37767, 37768, 37770, 37771, 37772, 37774, 37775, 37776, 37777, 37778, 37779, 37780, 37781, 37782, 37783, 37784, 37785, 37786, 37787, 37788, 37789, 37791, 37792, 37793, 37795, 37796, 37797, 37798, 37800, 37801, 37802, 37803, 37804, 37805, 37806, 37807, 37808, 37809, 37810, 37811, 37812, 37813, 37814, 37815, 37816, 37817, 37818, 37819, 37820, 37821, 37822, 37823, 37824, 37825, 37826, 37827, 37828, 37829, 37830, 37832, 37833, 37834, 37835, 37836, 37837, 37838, 37839, 37840, 37841, 37842, 37843, 37844, 37845, 37846, 37847, 37848, 37849, 37850, 37851, 37852, 37853, 37854, 37855, 37856, 37857, 37858, 37859, 37860, 37861, 37862, 37863, 37864, 37865, 37866, 37867, 37868, 37869, 37870, 37871, 37872, 37873, 37874, 37875, 37876, 37877, 37878, 37879, 37880, 37881, 37882, 37883, 37884, 37885, 37886, 37887, 37888, 37889, 37890, 37891, 37892, 37893, 37894, 37895, 37896, 37897, 37898, 37899, 37900, 37901, 37902, 37903, 37904, 37905, 37906, 37907, 37908, 37909, 37910, 37912, 37913, 37914, 37915, 37916, 37917, 37918, 37919, 37920, 37921, 37922, 37923, 37924, 37925, 37926, 37929, 37930, 37931, 37932, 37933, 37934, 37935, 37936, 37937, 37938, 37939, 37940, 37941, 37942, 37943, 37944, 37945, 37946, 37947, 37948, 37949, 37950, 37951, 37952, 37953, 37954, 37955, 37956, 37957, 37958, 37959, 37960, 37961, 37962, 37963, 37964, 37965, 37966, 37967, 37968, 37969, 37970, 37971, 37972, 37973, 37974, 37975, 37976, 37977, 37978, 37979, 37980, 37981, 37982, 37983, 37984, 37985, 37986, 37987, 37988, 37989, 37990, 37991, 37993, 37994, 37995, 37996, 37997, 37998, 37999, 38000, 38001, 38002, 38003, 38004, 38005, 38006, 38007, 38010, 38011, 38014, 38015, 38016, 38017, 38018, 38019, 38020, 38021, 38022, 38023, 38024, 38025, 38026, 38027, 38028, 38029, 38030, 38031, 38032, 38033, 38034, 38035, 38036, 38037, 38038, 38039, 38040, 38041, 38042, 38043, 38044, 38045, 38046, 38047, 38048, 38049, 38050, 38051, 38052, 38053, 38054, 38055, 38056, 38057, 38058, 38059, 38060, 38061, 38062, 38063, 38064, 38065, 38066, 38067, 38068, 38069, 38070, 38071, 38072, 38073, 38074, 38075, 38076, 38077, 38078, 38079, 38080, 38081, 38082, 38083, 38084, 38085, 38086, 38087, 38088, 38089, 38090, 38091, 38092, 38093, 38094, 38095, 38096, 38097, 38098, 38099, 38100, 38101, 38102, 38103, 38105, 38106, 38109, 38110, 38111, 38112, 38113, 38114, 38115, 38116, 38117, 38119, 38120, 38121, 38122, 38123, 38124, 38125, 38126, 38127, 38128, 38129, 38132, 38133, 38134, 38135, 38137, 38138, 38139, 38140, 38142, 38143, 38144, 38146, 38147, 38148, 38149, 38150, 38151, 38153, 38154, 38155, 38156, 38157, 38159, 38160, 38186, 38187, 38188, 38189, 38190, 38191, 38192, 38194, 38195, 38196, 38197, 38198, 38199, 38200, 38201, 38202, 38203, 38204, 38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38216, 38217, 38218, 38220, 38221, 38222, 38223, 38225, 38226, 38227, 38228, 38229, 38230, 38231, 38232, 38233, 38234, 38235, 38236, 38237, 38238, 38239, 38240, 38242, 38243, 38244, 38245, 38246, 38247, 38248, 38249, 38250, 38251, 38252, 38253, 38254, 38255, 38256, 38257, 38258, 38259, 38260, 38261, 38262, 38263, 38264, 38265, 38266, 38267, 38268, 38269, 38270, 38271, 38272, 38273, 38274, 38275, 38276, 38277, 38278, 38279, 38280, 38281, 38283, 38284, 38285, 38286, 38287, 38288, 38289, 38290, 38292, 38293, 38294, 38295, 38296, 38297, 38299, 38300, 38301, 38302, 38303, 38304, 38305, 38308, 38309, 38310, 38311, 38312, 38313, 38314, 38315, 38316, 38317, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 38325, 38326, 38327, 38328, 38329, 38330, 38331, 38332, 38333, 38334, 38335, 38336, 38337, 38338, 38339, 38340, 38341, 38342, 38343, 38344, 38345, 38346, 38347, 38348, 38349, 38350, 38351, 38352, 38353, 38354, 38355, 38356,38357, 38358, 38359 38360, 38361, 38362, 38363, 38364, 38365, 38366, 38367, 38368, 38369, 38370, 38371, 38372, 38373, 38374, 38375, 38376, 38377, 38378, 38379, 38380, 38381, 38382, 38383, 38384, 38385, 38386, 38387, 38388, 38390, 38391, 38392, 38393, 38394, 38395, 38396, 38397, 38398, 38399, 38400, 38401, 38402, 38403, 38404, 38405, 38406, 38407, 38408, 38409, 38410, 38411, 38412, 38413, 38414, 38415, 38416, 38417, 38418, 38419, 38420, 38421, 38422, 38423, 38424, 38425, 38426, 38427, 38428, 38429, 38430, 38456, 38457, 38458, 38459, 38460, 38461, 38462, 38463, 38464, 38465, 38466, 38467, 38469, 38470, 38471, 38472, 38473, 38474, 38475, 38476, 38477, 38478, 38479, 38480, 38481, 38482, 38484, 38485, 38486, 38487, 38488, 38489, 38490, 38491, 38492, 38493, 38494, 38495, 38496, 38497, 38498, 38499, 38500, 38501, 38502, 38503, 38504, 38505, 38506, 38507, 38508, 38509, 38510, 38511, 38512, 38513, 38514, 38515, 38516, 38517, 38518, 38519, 38520, 38521, 38522, 38523, 38524, 38525, 38526, 38527, 38528, 38529, 38530, 38531, 38532, 38533, 38534, 38535, 38536, 38537, 38538, 38539, 38540, 38541, 38542, 38543, 38544, 38545, 38547, 38548, 38549, 38550, 38551, 38552, 38553, 38554, 38555, 38556, 38557, 38558, 38559, 38560, 38561, 38562, 38563, 38564, 38565, 38566, 38567, 38568, 38569, 38570, 38571, 38572 38573, 38574, 38575, 38576, 38577, 38578, 38579, 38580, 38581, 38582, 38583, 38584, 38585, 38586 38587, 38589, 38590, 38591, 38592, 38593, 38594, 38595, 38596, 38597, 38598, 38599, 38601, 38602, 38603, 38604, 38605, 38606, 38607, 38608, 38609, 38610, 38611, 38612, 38613, 38614, 38615, 38616, 38617, 38618, 38619, 38620, 38621, 38622, 38623, 38625, 38626, 38627, 38628, 38629, 38630, 38631, 38632, 38633, 38634, 38635, 38636, 38637, 38638, 38639, 38640, 38641, 38642, 38643, 38644, 38645, 38646, 38647, 38648, 38649, 38650, 38651, 38652, 38653, 38654, 38655, 38656, 38657, 38658, 38659, 38660, 38661, 38662, 38663, 38664, 38665, 38666, 38667, 38668, 38669, 38671, 38672, 38673, 38674, 38675, 38676, 38678, 38679, 38680, 38681, 38682, 38683, 38684, 38685, 38686, 38687, 38688, 38691, 38692, 38693, 38695, 38696, 38697, 38698, 38699, 38700, 38701, 38702, 38703, 38704, 38705, 38706, 38707, 38708, 38709, 38710, 38711, 38712, 38713, 38714, 38715, 38716, 38717, 38718, 38719, 38720, 38721, 38722, 38723, 38724, 38725, 38726, 38727, 38728, 38729, 38730, 38732, 38733, 38734, 38735, 38736, 38737, 38738, 38739, 38740, 38741, 38743, 38744, 38745, 38746, 38747, 38748, 38749, 38752, 38753, 38754, 38756, 38759, 38761, 38762, 38763, 38764, 38765, 38766, 38767, 38768, 38769, 38770, 38771, 38772, 38773, 38774, 38775, 38777, 38778, 38779, 38780, 38781, 38782, 38783, 38784, 38785, 38786, 38787, 38788, 38789, 38790, 38791, 38792, 38793, 38794, 38795, 38796, 38797, 38798, 38799, 38800, 38801, 38802, 38803, 38804, 38805, 38806, 38807, 38808, 38809, 38810, 38811, 38812, 38813, 38814, 38815, 38816, 38817, 38818, 38819, 38820, 38821, 38822, 38823, 38824, 38825, 38826, 38827, 38828, 38829, 38830, 38831, 38832, 38833, 38834, 38835, 38836, 38837, 38838, 38840, 38841, 38842 38843, 38844, 38845, 38846, 38847, 38848, 38849, 38850, 38851, 38852, 38853, 38854, 38855, 38856, 38857, 38858, 38859, 38860, 38861, 38862, 38863, 38864, 38865, 38866, 38867, 38868, 38869, 38870, 38871, 38872, 38873, 38874, 38875, 38876, 38877, 38878, 38879, 38880, 38881, 38882, 38883, 38884, 38885, 38886, 38887, 38888, 38889, 38890, 38891, 38892, 38893, 38894, 38960, 38961, 38962, 38963, 38965, 38966, 38968, 38969, 38970, 38971, 38972, 38973, 38974, 38976, 38977, 38978, 38979, 38980, 38981, 38982, 38983, 38984, 38985, 38986, 38987, 38988, 38989, 39128, 39138, 39171, 39172, 39173, 39174, 39175, 39176, 39177, 39181, 39182, 39184, 39185, 39191, 39194, 39196, 39198, 39199, 39200, 39201, 39202, 39215, 39216, 39217, 39219, 39223, 39224, 39348, 39349, 39350, 39351, 39352, 39353, 39360, 39375, 39378, 39379, 39380, 39381, 39382, 39385, 39388, 39389, 39390, 39391, 39392, 39393, 39394, 39395, 39405, 39406, 39407, 39468, 39469, 39470, 39471, 39472, 39473, 39475, 39476, 39477, 39478, 39479, 39480, 39482, 39484, 39485, 39486, 39487, 39489, 39490, 39493, 39494, 39495, 39496, 39497, 39498, 39499, 39500, 39504, 39512, 39513, 39515, 39518, 39519, 39520, 39521, 39525, 39527, 39560, 39561, 39562, 39563, 39564, 39565, 39566, 39567, 39569, 39571, 39572, 39573, 39574, 39577, 39578, 39579, 39581, 39582, 39583, 39584, 39586, 39587, 39588, 39590, 39591, 39593, 39594, 39597, 39598, 39599, 39600, 39601, 39606, 39607, 39609, 39610, 39612, 39613, 39614, 39615, 39616, 39617, 39632, 39654, 39656, 39657, 39658, 39659, 39661, 39662, 39663, 39664, 39666, 39668, 39670, 39671, 39672, 39674, 39675, 39677, 39678, 39679, 39681 and 39682;
 
c) a) Serial Numbers: 14532, 14544, 14546, 14590, 14591, 14592, 14593, 14594, 14595, 14596, 14597, 14598, 14599, 14600, 14601, 14602, 14603, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14650, 14654, 14655, 14657, 14663, 14666, 14669, 14670, 14671, 14678, 14679, 14680, 14681, 14682, 14683, 14684, 14685, 14687, 14688, 14690, 14691, 14694, 14695, 14696, 14697, 14698, 14699, 14700, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 15269, 15272, 15303, 15304, 15305, 15306, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15317, 15318, 15319, 15320, 15321, 15322, 15323, 15324, 15325, 15326, 15327, 15328, 15329, 15330, 15331, 15332, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15492, 15493, 15496, 15497, 15499, 15500, 15501, 15502 and 15504. b) Serial Numbers: 11112, 11113, 11114, 11115, 11121, 11123, 11124, 11125, 11126, 11129, 11160, 11161, 11163, 11164, 11165, 11166, 11167, 11169, 11170, 11171, 11172, 11173, 11174, 11175, 11176, 11177, 11178, 11179, 11180, 11181, 11182, 11183, 11184, 11185, 11186, 11188, 11189, 11190, 11191, 11196, 11201, 11208, 11215, 11216, 11217, 11218, 11250, 11251, 11254, 11255, 11256, 11257, 11259, 11260, 11261, 11262, 11263, 11265, 11267, 11269, 11270, 11271, 11272, 11273, 11274, 11275, 11277, 11278, 11280, 11281, 11282, 11283, 11284, 11285, 11286, 11287, 11288, 11289, 11290, 11291, 11292, 11293, 11294, 11295, 11296, 11297, 11298, 11299, 11300, 11301, 11302, 11303, 11304, 11305, 11306, 11307, 11308, 11309, 11324, 11325, 11326, 11327, 11328, 11329, 11330, 11331, 11332, 11333, 11334, 11406, 11413, 11414, 11416, 11418, 11430, 11432, 11435, 11437, 11438, 11439, 11443, 11445, 11446, 11449, 11452, 11453, 11454, 11499, 11501, 11508, 11510 and 11517;
  
d) a) Serial Numbers:14122, 14124, 14125, 14126, 14127, 14128, 14129, 14130, 14132, 14133, 14134, 14135, 14137, 14138, 14139, 14141, 14142, 14143, 14144, 14145, 14147, 14148, 14149, 14150, 14151, 14152, 14153, 14155, 14156, 14157, 14158, 14159, 14160, 14161, 14162, 14163, 14164, 14166, 14168, 14169, 14170, 14171, 14715, 14716, 14717, 14718, 14719, 14720, 14721, 14722, 14723, 14724, 14725, 14726, 14727, 14730, 14732, 14735, 14736, 14741, 14742, 14743, 14800, 14955, 14956, 14964, 14971, 15105, 15106, 15107, 15110, 15111, 15112, 15117, 15118 and 15120. b) Serial Numbers: 10250, 10251, 10252, 10254, 10255, 10256, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10340, 10341, 10342, 10344, 10345, 10346, 10348, 10352, 10354, 10362, 10367, 10374, 10375, 10378, 10559, 10561, 10566, 10572, 10573, 10577, 10578, 10582, 10583, 10586, 10587, 10588, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10663, 10664, 10665, 10666, 10668, 10669, 10670, 10673, 10674, 10675, 10676, 10677, 10678, 10682, 10684, 10702, 10705, 10769, 10770, 10771, 10773 and 10774
RECALLING FIRM/MANUFACTURER 
Advanced Bionics LLC, Sylmar , CA , by letter on July 24, 2008. Firm initiated recall is ongoing.
REASON 
Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps.
VOLUME OF PRODUCT IN COMMERCE 
Approximately 4,617 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. Recall # Z-0960-2009;
 
b) PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. Recall # Z-0961-2009
CODE 
a) Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141;
 
b) Lot numbers: A55827, A59222, A62005, A62127, A62349, A63526, and A63779
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Smith & Nephew Inc., Memphis ,  TN , by e-mail on November 21, 2008.
Manufacturer: Smith & Nephew Orthopaedics Ag, Rotkreuz , Switzerland . Firm initiated recall is ongoing.
REASON 
The product was breaking during use.
VOLUME OF PRODUCT IN COMMERCE 
159 Clamps and 51 Adapters
DISTRIBUTION 
International distribution only. Germany , France , Italy Austria , Switzerland , Belgium , United Kingdom , Greece , Australia , South Africa , Spain , and Cypress
___________________________________ 
PRODUCT 
Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile. Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. Recall # Z-0962-2009
CODE 
Lot number: 1563796
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Biomet, Inc., Warsaw , IN , by telephone and letter dated December 19, 2008.
Manufacturer: Biomet U.K. , Ltd, Bridgend, South Wales, UK . Firm initiated recall is ongoing.
REASON 
Packages labeled as “right” actually contain a “left” component.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MA and WV
___________________________________ 
PRODUCT 
a) NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery. Recall # Z-0963-2009;
 
b) NFix II System 200 mm, Catalog number NX60200-1. Spinal fusion surgery. Recall # Z-0964-2009;
 
c) N-Hance System 150 mm, Catalog number NH60150-1. Spinal fusion surgery, Recall # Z-0965-2009;
 
d) TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S Spinal fusion surgery. Recall # Z-0966-2009;
 
e) NFlex Stabilization System 200 mm, Catalog number NF60020-1. Spinal fusion surgery. Recall # Z-0967-2009;
  
f) NFlex Stabilization System 150 mm, Catalog number NF60150-1. Spinal fusion surgery. Recall # Z-0968-2009
CODE 
a) Lot numbers: P06J01 exp 9/30/07; P06J02 exp 9/30/07; P06M01 exp 12/31/07; P06M02 exp 12/31/07; P07D02 exp 4/30/08; P07H01 exp 8/31/08; and P07J01 exp 9/30/08;
 
b) Lot number: P07G01 exp 7/31/08;
 
c) Lot number: P07M01 exp 12/31/08;
 
d) Lot number: 5764185 exp 5/20/2013;
 
e) Lot number: NF60003 exp 3/31/07;
f) Lot numbers: P07M01 exp 12/31/08; P07M03 exp 12/31/08; P06H01 exp 8/31/07; P06M01 exp 12/31/07; and P06J01 exp 9/30/07
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Synthes Spine, West Chester ,  PA , by e-mail on November 18, 2008 and by letters dated November 19, 2008.
Manufacturer: Synthes ( USA ), Monument, CO. Firm initiated recall is ongoing. 
REASON 
The dimensional specifications are incorrect.
VOLUME OF PRODUCT IN COMMERCE 
1,508 units
DISTRIBUTION 
Nationwide and countries of Germany , Denmark , Switzerland and Korea
___________________________________ 
PRODUCT 
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0970-2009
CODE 
Software versions 2.1.X and 3.0.X and higher with Talk Extend
RECALLING FIRM/MANUFACTURER 
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 10, 2008. Firm initiated recall is ongoing.
REASON 
Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
VOLUME OF PRODUCT IN COMMERCE 
22 units
DISTRIBUTION 
CA, FL, IL, IA, LA, OR, PA, TX, UT, VA, and WI
 
END OF ENFORCEMENT REPORT FOR FEBRUARY 18, 2009

 

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