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Showing 64501–64520 of 68218 results

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Conmed Electrosurgery: Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS,...

Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

FDASep 5, 2006Nationwide• Conmed Electrosurgery

Conmed Electrosurgery: Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS,...

Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

FDASep 5, 2006Nationwide• Conmed Electrosurgery

Siemens Medical Solutions USA, Inc: syngo Imaging, picture archiving and communications syste...

Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

FDASep 5, 2006Nationwide• Siemens Medical Solutions USA, Inc

Stryker Spine: Stryker Trio Small Offset Connector Non Sterile; Manufact...

Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.

FDASep 5, 2006Nationwide• Stryker Spine

Tosoh Bioscience Inc: TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalo...

Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument

FDASep 1, 2006Nationwide• Tosoh Bioscience Inc

MAQUET Inc.: Jostra - HL-20 Heart Lung Integrated Perfusion System, Ro...

The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

FDASep 1, 2006Nationwide• MAQUET Inc.

AGFA Corp.: CR NX Modality Workstation, Computed Radiography System (...

Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.

FDASep 1, 2006Nationwide• AGFA Corp.

Elekta, Inc.: Leksell Gamma Knife C

Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.

FDASep 1, 2006Nationwide• Elekta, Inc.

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.

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

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

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm,...

Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

FDAAug 31, 2006AR, CA, GA +7 more• Smiths Medical ASD, Inc.

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

Boston Scientific: Boston Scientific PT2 Light Support Guide Wire 185cm J-Ti...

The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

FDAAug 31, 2006AZ, AR, CA +30 more• Boston Scientific

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.

Boston Scientific: Boston Scientific PT2 Moderate Support Guide Wire 185cm J...

The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

FDAAug 31, 2006AZ, AR, CA +30 more• Boston Scientific

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.

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

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

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