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Showing 66841–66860 of 68218 results

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Cardinal Health: Jackson-Pratt Reservoir, 400 mL suction reservoir; a ster...

The products labeled as sterile are not sterile.

FDAJul 28, 2004AZ, FL, NJ• Cardinal Health

Siemens Medical Solutions USA, Inc: Magnetom Harmony MRI System Model number 7106714

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Magnetom Sonata MRI System, Model 7388148

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Magnetom Avanto MRI System, Model 7391167

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD.

FDAJul 28, 2004MI• Cryolife Inc

Ortho-Clinical Diagnostics: VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box...

The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

FDAJul 28, 2004Nationwide• Ortho-Clinical Diagnostics

Siemens Medical Solutions USA, Inc: Magnetom Trio MRI System, Model 7106441

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Cardinal Health: Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone w...

The products labeled as sterile are not sterile.

FDAJul 28, 2004AZ, FL, NJ• Cardinal Health

Siemens Medical Solutions USA, Inc: Magnetom Symphony MRI System, Model 7106557

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Datascope Corp: Trio Monitor. Cardiac Monitor (including cardiotachomete...

The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

FDAJul 28, 2004Nationwide• Datascope Corp

Greiner VACUETTE North America: Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3...

Coagulation tubes may not have received the proper fill of citrate solution.

FDAJul 27, 2004Nationwide• Greiner VACUETTE North America

Advanced Bionics Corporation: Auria PowerPak, Model CI-7400-xxx where xxx denotes color...

Battery pack may overheat and cause patient burns.

FDAJul 27, 2004Nationwide• Advanced Bionics Corporation

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creati...

Precipitate formed in product.

FDAJul 27, 2004Nationwide• Abbott Laboratories Diagnostic Div

Baxter Healthcare Renal Div: Accura System for Blood Filtration, product codes 5M5660...

The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient's treatment

FDAJul 26, 2004Nationwide• Baxter Healthcare Renal Div

Invacare Corporation: ICCG AC-Powered Adjustable Medical Bed

Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure.

FDAJul 23, 2004Nationwide• Invacare Corporation

Medtronic Inc, Neurological & Spinal Division: The Model 8540 Catheter Access Port Kit is intended for u...

The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

FDAJul 23, 2004IN• Medtronic Inc, Neurological & Spinal Division

Unknown Manufacturer: ADP 3.2 Adapter, non sterile reusable Model Number: 30-8...

Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

FDAJul 22, 2004Nationwide

Unknown Manufacturer: ADP2.1 Adapter, non-sterile reusable Model Number: 30-80...

Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

FDAJul 22, 2004Nationwide

Dade Behring Inc. Rte 896, Glasgow Business Community: BC Thrombin Reagent . Thrombin Time Test

The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

FDAJul 21, 2004CT, FL, IL +5 more• Dade Behring Inc. Rte 896, Glasgow Business Community

Philips Medical Systems Sales & Service Region No. America: BV212 Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

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