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Showing 64861–64880 of 68218 results

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Rita Medical Systems, Inc.: XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Me...

Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker

FDAMay 2, 2006AL, AR, FL +8 more• Rita Medical Systems, Inc.

Rita Medical Systems, Inc.: Talon Straight, 25 cm--Electrosurgical Device--RITA * Med...

Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.

FDAMay 2, 2006AL, AR, FL +8 more• Rita Medical Systems, Inc.

Radiometer America Inc: Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cart...

Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.

FDAMay 1, 2006Nationwide• Radiometer America Inc

Varian Medical Systems: GammaWin software, part number GM11019110, versions up to...

Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.

FDAMay 1, 2006Nationwide• Varian Medical Systems

Varian Medical Systems: GammaMed software program, version 5.07, vers. 5.08, vers...

Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.

FDAMay 1, 2006Nationwide• Varian Medical Systems

Bard Peripheral Vascular Inc: Bard TruGuide Coxail Biopsy Needle with Depth Stop and ad...

Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.

FDAMay 1, 2006CA, FL, IN +4 more• Bard Peripheral Vascular Inc

Medisurg Research & Management Corp: Fugo Blade Incising Tip Assembly. Incising tips to be use...

No documentation to support shelf life/sterility

FDAApr 28, 2006Nationwide• Medisurg Research & Management Corp

Nicolet Biomedical Div of Viasys Healthcare: VIASYS Healthcare Disposable Bar Electrodes. Re-order No...

The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is used as a bar.

FDAApr 28, 2006AL, CA, CT +6 more• Nicolet Biomedical Div of Viasys Healthcare

Siemens Medical Solutions USA, Inc: 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount

Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.

FDAApr 28, 2006Nationwide• Siemens Medical Solutions USA, Inc

Instrumentarium Dental, Inc.: Cranex Tome panoramic x-ray unit with Spiral Tomography f...

There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.

FDAApr 28, 2006Nationwide• Instrumentarium Dental, Inc.

W L Gore & Assoc, Inc.: GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Gra...

Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.

FDAApr 28, 2006Nationwide• W L Gore & Assoc, Inc.

Hitachi Medical Systems America Inc: AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Devi...

Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.

FDAApr 28, 2006CO, IN, NE +2 more• Hitachi Medical Systems America Inc

Stryker Howmedica Osteonics Corp.: Lateral Decubitus Alignment Guide, Non Sterile; manual su...

The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock.

FDAApr 27, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Zimmer Inc.: Quicklock Tracker, Size 2, Manufactured by Orthosoft, Mon...

The three-point array may break during use, resulting in surgical delay and an increased risk of infection.

FDAApr 27, 2006Nationwide• Zimmer Inc.

Ethicon, Inc. US: Heartport Direct Flow Arterial Cannula, product code DFK2...

During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.

FDAApr 27, 2006IN• Ethicon, Inc. US

Boston Scientific Target: Boston Scientific brand Pivot Steerable Microcatheter, 1....

During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.

FDAApr 26, 2006IN, OR• Boston Scientific Target

Hitachi Medical Systems America Inc: Hitachi AIRIS II MRI System

Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.

FDAApr 25, 2006Nationwide• Hitachi Medical Systems America Inc

Kyphon Inc: Functional Anaesthetic Discography (F.A.D.) Catheter Sys...

Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

FDAApr 25, 2006Nationwide• Kyphon Inc

Philips Medical Systems (Cleveland) Inc: Brilliance CT (computed tomography) scanners, Big Bore co...

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.

FDAApr 25, 2006CA, NV• Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc: Brilliance CT (computed tomography) scanners, Big Bore co...

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.

Class IIModerate

FDAApr 25, 2006CA, NV• Philips Medical Systems (Cleveland) Inc

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