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Showing 18681–18700 of 22584 results

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Stryker Howmedica Osteonics Corp.: Duracon Total Knee Modular Femoral Component; Non-Porous ...

Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

FDAOct 17, 2006GA, IN• Stryker Howmedica Osteonics Corp.

Cyberonics, Inc: Handhelds-Cyberonics VNS Therapy System, Model 250-''Hand...

During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

FDAOct 17, 2006Nationwide• Cyberonics, Inc

Cyberonics, Inc: Cyberonics VNS Therapy System, Model 250-''HAND HELD'' pr...

During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

FDAOct 17, 2006Nationwide• Cyberonics, Inc

Medishop USA: OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test...

Counterfeit-(manufacturer unknown)

FDAOct 17, 2006MS, NJ, NY• Medishop USA

Beckman Coulter Inc: FC 500 MPL Flow Cytometry System with MXP Software Versio...

The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.

FDAOct 17, 2006Nationwide• Beckman Coulter Inc

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 6 inch diameter Rolle...

The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as zero, even when the battery is fully functional.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Rolle...

The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Unknown Manufacturer: EP Healing abutment- Product Code-ITHA52-a pre-manufactur...

Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.

FDAOct 16, 2006Nationwide

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; Air Bubble Detection ...

The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Rolle...

The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Invacare Corporation: Invacare AC-Powered Adjustable Hospital Bed. Model 5890 I...

Invacare Corporation, Florida issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006.

FDAOct 16, 2006Nationwide• Invacare Corporation

Core Care Technologies, Inc: One Touch Basic/Profile and One Touch Ultra Blood Glucose...

Counterfeit product (manufacturer unknown)

FDAOct 14, 2006Nationwide• Core Care Technologies, Inc

Boston Scientific Target: Boston Scientific brand Renegade 18 Fiber braided microca...

Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)

FDAOct 13, 2006Nationwide• Boston Scientific Target

Medical Plastics Devices Inc: One Touch Basic/Profile Blood Glucose test strips

Counterfeit Glucose Test Strips (manufacturer unknown)

FDAOct 13, 2006Nationwide• Medical Plastics Devices Inc

Medical Plastics Devices Inc: One Touch Ultra Blood Glucose Test Strips

Counterfeit Glucose Test Strips (manufacturer unknown)

FDAOct 13, 2006Nationwide• Medical Plastics Devices Inc

Conmed Corporation: ConMed Laparoscopic Instrument: Allis Disposable Grasper,...

The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

FDAOct 12, 2006Nationwide• Conmed Corporation

Zimmer Inc.: Zimmer NexGen Complete Knee Solution Legacy Knee Tibial C...

The polyethylene tibial articular surface may not lock into some of the tibial plates.

FDAOct 12, 2006Nationwide• Zimmer Inc.

Philips Medical Systems North America Co. Phillips: Allura Xper FD 20/10 x-ray, and fluoroscopy

Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.

FDAOct 12, 2006Nationwide• Philips Medical Systems North America Co. Phillips

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