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Showing 64301–64320 of 68218 results

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Welch Allyn Protocol, Inc: Propaq LT vital signs monitor, Model 802LTON

Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.

FDAOct 22, 2006Nationwide• Welch Allyn Protocol, Inc

Viasys Respiratory Care, Inc.: Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Num...

The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.

FDAOct 20, 2006Nationwide• Viasys Respiratory Care, Inc.

Viasys Respiratory Care, Inc.: Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog...

The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.

FDAOct 20, 2006Nationwide• Viasys Respiratory Care, Inc.

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek Bone fragmentor Ref Number/Model ...

Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

FDAOct 20, 2006Nationwide• Medtronic Sofamor Danek USA Inc

Discount Diabetic Supply: One Touch Ultra Blood Glucose test strips, LifeScan, a J...

Counterfeit-blood glucose test strips (manufacturer unknown)

FDAOct 19, 2006Nationwide• Discount Diabetic Supply

Zimmer Inc.: Zimmer Trabecular metal shoulder instrumentation proximal...

The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.

FDAOct 19, 2006Nationwide• Zimmer Inc.

Ascent Healthcare Solutions, Inc.: AutoSuture Bladed Trocar, equipped with safety shield. Mo...

The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.

FDAOct 19, 2006Nationwide• Ascent Healthcare Solutions, Inc.

Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. Catalog Number 31162...

Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.

FDAOct 18, 2006Nationwide• Roche Diagnostics Corp.

Continental Medical Labs, Inc: Fibrin Analysis Catheter Testing System includes the comp...

Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.

FDAOct 18, 2006IN, WI• Continental Medical Labs, Inc

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.

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

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

Counterfeit-(manufacturer unknown)

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

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

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

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

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

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; 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

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