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Showing 62241–62260 of 68218 results

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Siemens Medical Solutions USA, Inc: Radiation therapy system - PRIMEVIEW 3i System equipped w...

Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

FDAMay 15, 2008Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Radiation therapy system - AG Therapist 3rd party V&R equ...

Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

FDAMay 15, 2008Nationwide• Siemens Medical Solutions USA, Inc

Biomet, Inc.: Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 ...

Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.

FDAMay 15, 2008Nationwide• Biomet, Inc.

Merit Medical Systems, Inc.: Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Mer...

Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.

FDAMay 14, 2008Nationwide• Merit Medical Systems, Inc.

Stryker Howmedica Osteonics Corp.: Stem Trial, Triathlon Revision Instruments; Non-Sterile; ...

Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.

FDAMay 14, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 1.5....

In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.

FDAMay 14, 2008Nationwide• Computerized Medical Systems Inc

Synovis Micro Companies Alliance Inc: GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF G...

Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.

FDAMay 14, 2008Nationwide• Synovis Micro Companies Alliance Inc

Beevers Manufacturing & Supply, Inc.: Cannulaide, Model 101, 102, 103. Respirator. The Cannu...

Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.

FDAMay 13, 2008CA, FL, GA +4 more• Beevers Manufacturing & Supply, Inc.

Toshiba American Medical Systems Inc: TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a w...

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

FDAMay 13, 2008Nationwide• Toshiba American Medical Systems Inc

Physio Control, Inc.: Keypad replacement for LIFEPAK20 or LIFEPAK20e. This pro...

A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20e defibrillator/monitor. This p...

A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Toshiba American Medical Systems Inc: TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a ...

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

Class IIModerate

FDAMay 13, 2008Nationwide• Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc: EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 ...

The status display in the sequence queue window may not change from "Current" to "Done".

Class IIModerate

FDAMay 13, 2008Nationwide• Toshiba American Medical Systems Inc

Beevers Manufacturing & Supply, Inc.: Cannulaide, Model 101, 102, 103. Respirator. The Can...

Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.

Class IIModerate

FDAMay 13, 2008CA, FL, GA +4 more• Beevers Manufacturing & Supply, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20 defibrillator/monitor. This pr...

A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Toshiba American Medical Systems Inc: EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 ...

The status display in the sequence queue window may not change from "Current" to "Done".

FDAMay 13, 2008Nationwide• Toshiba American Medical Systems Inc

Acumed LLC: Modular Shoulder Body Assembly, Left (SH-1540L-S) and Mod...

The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.

FDAMay 13, 2008AL, CA, GA +2 more• Acumed LLC

Telefelx Medical: Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elas...

The bands are breaking within the sealed packaging or in use prior to the expiration dates.

FDAMay 12, 2008PR• Telefelx Medical

Clinical Innovations, LLC: ClearView Uterine Manipulator, Long tip version with disp...

Inadequate package seal could compromise sterility.

FDAMay 12, 2008CA, CO, FL +3 more• Clinical Innovations, LLC

Atrium Medical Corporation: ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atri...

Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

FDAMay 12, 2008Nationwide• Atrium Medical Corporation

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