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Showing 18881–18900 of 22584 results

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Teknimed SA 11 Rue Apollo L France: OsSatura TCP (pure tricalcium phosphate) 3mm granules pac...

The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.

FDAAug 31, 2006Nationwide• Teknimed SA 11 Rue Apollo L France

Varian Medical Systems Inc: Clinac High Energy Medical Linear Accelerator, Medical Ch...

The chain holding the device gantry in position may break.

FDAAug 31, 2006Nationwide• Varian Medical Systems Inc

Puritan Bennett Corporation: Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catal...

Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.

FDAAug 31, 2006PR• Puritan Bennett Corporation

Exactech, Inc.: Optetrak, B-series cemented finned tibial tray size 2f/2t...

Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

FDAAug 31, 2006Nationwide• Exactech, Inc.

Arjo, Inc.: Minstrel Patient Lift with SR weighing scale; a non-AC-po...

The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.

FDAAug 31, 2006Nationwide• Arjo, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 external defibrillator/monitor

Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.

FDAAug 30, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Stryker Medical Div. of Stryker Corporation: Stryker Power-PRO Powered Ambulance Cot, Model 6500.

The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.

FDAAug 29, 2006Nationwide• Stryker Medical Div. of Stryker Corporation

Kerr Corp: OptiBond Solo Plus Self-Etch Adhesive System, Part Number...

Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

FDAAug 29, 2006Nationwide• Kerr Corp

Sebia, Inc.: HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnos...

The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

FDAAug 29, 2006Nationwide• Sebia, Inc.

Beckman Coulter Inc: Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Pa...

Two workflow scenarios associated with renaming regions may produce incorrect results.

FDAAug 29, 2006Nationwide• Beckman Coulter Inc

Smith & Nephew Inc: Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbe...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Lumenis Inc.: Lumenis brand DuoTome SideLite 550 Micron Delivery System...

Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.

FDAAug 29, 2006Nationwide• Lumenis Inc.

Smith & Nephew Inc: Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers:...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Smith & Nephew Inc: Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Cat...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Olsen Medical: MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electro...

Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.

FDAAug 29, 2006Nationwide• Olsen Medical

Beckman Coulter Inc: CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 C...

Two workflow scenarios associated with renaming regions may produce incorrect results.

FDAAug 29, 2006Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1...

Two workflow scenarios associated with renaming regions may produce incorrect results.

FDAAug 29, 2006Nationwide• Beckman Coulter Inc

Thoratec Corp: Thoratec brand TLC-II Portable Ventricular Assist Device ...

Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.

FDAAug 25, 2006AL, CA, CT +18 more• Thoratec Corp

Nicolet Biomedical Div of Viasys Healthcare: NicoletOne version 5.20 software (also known as NicoletOn...

A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.

FDAAug 25, 2006Nationwide• Nicolet Biomedical Div of Viasys Healthcare

Drew Scientific Group PLC: Drew Excell 22 Hematology Analyzer, manufactured by Drew ...

Flags and alerts on the user interface will not automatically transfering to the LIS.

FDAAug 24, 2006FL, MA, MN +5 more• Drew Scientific Group PLC

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