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Showing 63421–63440 of 68218 results

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Summit Industries Inc.: LX125 Swivel Collimator, Model D800; Manual Radiographic ...

The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

FDAAug 10, 2007Nationwide• Summit Industries Inc.

Becton Dickinson & Company: Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surg...

Complaints received of rust on the blades of BD Bard-Parker Surgical blades.

FDAAug 10, 2007Nationwide• Becton Dickinson & Company

Abbott Laboratories Inc.: Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bi...

Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.

FDAAug 10, 2007PR• Abbott Laboratories Inc.

Linvatec Corp.: ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, L...

Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

FDAAug 9, 2007Nationwide• Linvatec Corp.

Biomet, Inc.: Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, T...

Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

FDAAug 9, 2007Nationwide• Biomet, Inc.

Unknown Manufacturer: EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #8...

Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

FDAAug 9, 2007CA, FL, IN +1 more

Becton Dickinson and Company: BD Microkeratome K3000 and K4000;Catalog Number: 378660,...

Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea

FDAAug 9, 2007Nationwide• Becton Dickinson and Company

VNUS Medical Technologies Inc: VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm wo...

Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.

FDAAug 8, 2007Nationwide• VNUS Medical Technologies Inc

BD Diagnostic Systems Lee Laboratories: DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catal...

Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.

FDAAug 8, 2007Nationwide• BD Diagnostic Systems Lee Laboratories

Unknown Manufacturer: Encore Reverse Shoulder Prosthesis (RSP) System, Standard...

Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.

FDAAug 8, 2007Nationwide

Siemens Medical Solutions USA, Inc: Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Par...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron KD2 Medical Charged-Particle Radiation T...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron K-2 Medical Charged-Particle Radiation T...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Seimens Mevatron M-2 6300 Medical Charged-Particle Radiat...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron MD2 Medical Charged-Particle Radiation T...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Seimens Mevatron M-2 6700 Medical Charged-Particle Radiat...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Pa...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Seimens Mevatron KD-2 Medical Charged-Particle Radiation ...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron KDS-2 Medical Charged-Particle Radiation...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mevatron MDX-2 Medical Charged-Particle Radiation...

Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

FDAAug 7, 2007Nationwide• Siemens Medical Solutions USA, Inc

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