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Showing 28941–28960 of 29086 results

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Xoran Technologies, Inc.: Xoran MiniCAT CT Scanner ID ENT00001

Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Class IIModerate

FDADec 14, 2009Nationwide• Xoran Technologies, Inc.

Rescue Me Supplement (GMP Laboratories) – Mispackaged Capsules (2009)

The firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product.

Class IIModerate

FDADec 8, 2009Nationwide• GMP Laboratories of America Inc

NAImco Inc dba Richmar Inc: Cloth electrodes with Silver-Carbon construction: P/N 20...

Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

Class IIModerate

FDANov 30, 2009GA, IN, TN• NAImco Inc dba Richmar Inc

NAImco Inc dba Richmar Inc: Cloth electrodes with Carbon construction: P/N 201-1231...

Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

Class IIModerate

FDANov 30, 2009GA, IN, TN• NAImco Inc dba Richmar Inc

NAImco Inc dba Richmar Inc: Foam Electrodes with Carbon construction: P/N 201-1261, ...

Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

Class IIModerate

FDANov 30, 2009GA, IN, TN• NAImco Inc dba Richmar Inc

NAImco Inc dba Richmar Inc: Foam electrodes with Silver-Carbon construction: P/N 202...

Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

Class IIModerate

FDANov 30, 2009GA, IN, TN• NAImco Inc dba Richmar Inc

CareFusion Corporation: Pyxis Anesthesia System Model 2000 (PAS 2000) Produc...

The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

Class IIModerate

FDANov 20, 2009Nationwide• CareFusion Corporation

Sunquest Information Systems, Inc.: Sunquest Application Interfacing Outbound Phlebotomy Poin...

The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.

Class IIModerate

FDANov 19, 2009Nationwide• Sunquest Information Systems, Inc.

Biosense Webster, Inc.: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is...

The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.

Class IIModerate

FDANov 17, 2009Nationwide• Biosense Webster, Inc.

Olympus America Inc.: Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")...

Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that

Class IIModerate

FDANov 10, 2009Nationwide• Olympus America Inc.

GE OEC Medical Systems, Inc: 892.1650 Image-intensified fluoroscopic x-ray system; the...

GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.

Class IIModerate

FDANov 6, 2009Nationwide• GE OEC Medical Systems, Inc

Terumo Cardiovascular Systems Corporation: Terumo Backplate Replacement CXFVR 1500 Holder The Fle...

Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a

Class IIModerate

FDAOct 2, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Kimberly-Clark Corporation: MicroCool Breathable Impervious Surgical Gown, (Large and...

Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Class IIModerate

FDASep 17, 2009Nationwide• Kimberly-Clark Corporation

Kimberly-Clark Corporation: MicroCool Breathable Impervious Gown with Secure Fit Surg...

Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Class IIModerate

FDASep 17, 2009Nationwide• Kimberly-Clark Corporation

Terumo Cardiovascular Systems Corporation: Safety monitor included with System 8000 Base The Sarn...

Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

Class IIModerate

FDAAug 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Toshiba American Medical Systems Inc: Whole Body X--ray Scanner This device is indicated as ...

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

Class IIModerate

FDAJul 13, 2009Nationwide• Toshiba American Medical Systems Inc

Orthosoft, Inc. dba Zimmer CAS: NDI P7 Position Sensor, Stereotaxic Instrument

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

Class IIModerate

FDAJun 9, 2009FL, IN, KS +5 more• Orthosoft, Inc. dba Zimmer CAS

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