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Showing 67141–67160 of 68218 results

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Roche Diagnostics Corp.: Tecan clinical workstation; 10-410 Tecan Genesis 150 back...

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Fujifilm Medical System USA, Inc.: Fuji Flash IIP and CR-IR346CL Consoles

Software: Incorrect measurement of objects within a CR image

FDAMay 5, 2004Nationwide• Fujifilm Medical System USA, Inc.

Roche Diagnostics Corp.: COBAS Gui software interface between the Cobas AMPLICOR i...

The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.

FDAMay 5, 2004CA, CT, IL +4 more• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150/8 front end...

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Boston Scientific Corp: ''NAMIC Custom Angiographic Kit'' sold under the followi...

Molded handles used in Angiographic Manifolds may be occluded.

FDAMay 5, 2004IL, IN, KY +3 more• Boston Scientific Corp

Medtronic Physio Control Corp: DC Power Adapter for use with the LIFEPAK 12 defibrillato...

The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.

FDAMay 5, 2004Nationwide• Medtronic Physio Control Corp

Cardiac Science, Inc.: FirstSave AED G3 Automated External Defibrillator Intelli...

Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.

FDAMay 4, 2004Nationwide• Cardiac Science, Inc.

Cardiac Science, Inc.: Power Heart AED G3 Automated External Defibrillator Intel...

Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.

FDAMay 4, 2004Nationwide• Cardiac Science, Inc.

Varian Medical Systems: VariSource High Dose Rate Afterloader, Models 200, 200t, ...

Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners.

FDAMay 4, 2004Nationwide• Varian Medical Systems

Tecan U S Inc: Tecan Clinical Workstations with Robonet software

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 3, 2004CA, CT, GA +12 more• Tecan U S Inc

Cypress Medical Products, Ltd.: Manual Mechanical Wheelchair, 24'' seat, , maximum patien...

The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.

FDAMay 3, 2004Nationwide• Cypress Medical Products, Ltd.

Diagnostic Products Corp: Immulite 1000 CEA Catalog No. LKCE1

Instabililty

FDAMay 3, 2004Nationwide• Diagnostic Products Corp

Cypress Medical Products, Ltd.: Manual Mechanical Wheelchair, 18'' seat, , maximum patien...

The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.

FDAMay 3, 2004Nationwide• Cypress Medical Products, Ltd.

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

The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.

FDAMay 1, 2004Nationwide• Terumo Cardiovascular Systems Corp

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

The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.

FDAMay 1, 2004Nationwide• Terumo Cardiovascular Systems Corp

ACMI CORPORATION: ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

Baxa Corporation: Exacta-Mix Valve Set, Secondary Valve Assembly

A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

FDAApr 30, 2004Nationwide• Baxa Corporation

Baxter Healthcare Corp. Rt.: Compounding Brochure titled ''Nutrition Compounding Simpl...

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

FDAApr 30, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Micromix Compounder Implementation Guide; this guide is d...

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

FDAApr 30, 2004Nationwide• Baxter Healthcare Corp. Rt.

ACMI CORPORATION: ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR ...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

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