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Showing 63061–63080 of 68218 results

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Bio-Rad Laboratories: BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test ...

False negative results due to reagent packs exhibiting low signal.

FDANov 13, 2007Nationwide• Bio-Rad Laboratories

AngioScore Inc.: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) ...

Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton

FDANov 13, 2007Nationwide• AngioScore Inc.

Bio-Rad Laboratories: BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 66...

False negative results due to reagent packs exhibiting low signal.

FDANov 13, 2007Nationwide• Bio-Rad Laboratories

Coloplast Corp: Coloplast Elefant Suction/Irrigation Cannula for Laparosc...

Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.

FDANov 12, 2007Nationwide• Coloplast Corp

Advanced Sterilization Products: STERRAD NX Sterilizer, Product Code: 10033, Advanced Ste...

User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

FDANov 12, 2007PR• Advanced Sterilization Products

McKesson Provider Technologies: Horizon Cardiology Hemo Monitoring System;Horizon Cardiol...

Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.

FDANov 12, 2007Nationwide• McKesson Provider Technologies

Arrow International Inc: ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0...

Leak may occur in the helium drive system for the IABP

FDANov 12, 2007CA, CO, FL +11 more• Arrow International Inc

Advanced Sterilization Products: STERRAD 200 Sterilizer, Product Code: 10201, Advanced Ste...

User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

FDANov 12, 2007PR• Advanced Sterilization Products

Toshiba American Medical Systems Inc: Xario; SSA-660A; software version 1.0 and later

Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

FDANov 12, 2007Nationwide• Toshiba American Medical Systems Inc

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: VectorVision (VV) Sky Navigation Platform (19" Computer R...

Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables.

FDANov 12, 2007Nationwide• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Toshiba American Medical Systems Inc: Aplio 50; SSA-700A; software version 5.5r002

Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

FDANov 12, 2007Nationwide• Toshiba American Medical Systems Inc

Advanced Sterilization Products: STERRAD 100S Sterilizer, Product Code: 10101, Advanced St...

User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

FDANov 12, 2007PR• Advanced Sterilization Products

Toshiba American Medical Systems Inc: Aplio 80; SSA-770A; software version 5.5r002

Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

FDANov 12, 2007Nationwide• Toshiba American Medical Systems Inc

Arrow International Inc: AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: ...

Leak may occur in the helium drive system for the IABP

FDANov 12, 2007CA, CO, FL +11 more• Arrow International Inc

Advanced Sterilization Products: STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Me...

Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities

FDANov 12, 2007PR• Advanced Sterilization Products

Advanced Sterilization Products: STERRAD 50 Sterilizer, Product Code:10050, Advanced Steri...

User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

FDANov 12, 2007PR• Advanced Sterilization Products

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek USA, CD Horizon Spinal System Agi...

Breaks: Shear failure of the cable component of the system.

FDANov 12, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Chiu Technical Corp: Transilluminator, Model BFO-150, a Fiber Optic Light Sour...

Device was marketed without a 510(k).

FDANov 9, 2007Nationwide• Chiu Technical Corp

General Electric Medical Systems Information Technology: GE Medical Systems Information Technologies Clinical Info...

Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.

FDANov 8, 2007AL, AZ, AR +42 more• General Electric Medical Systems Information Technology

Vital Images, Inc.: Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT V...

Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not up

FDANov 8, 2007CA, CO, FL +7 more• Vital Images, Inc.

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