BEUDAMED
    FDA Recall Terminated

    ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

    Recall: Z-3282-2011 · Initiated August 18, 2011

    Recall

    Recall Number
    Z-3282-2011
    Event Number
    59527
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 18, 2011
    Posted
    September 27, 2011
    Terminated
    August 9, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

    Reason

    GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.

    Action

    GE Healthcare sent "Urgent Medical Device Correction" letters dated August 18, 2011 to all affected customers. The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade. For question of this recall contact the GE Service Representative at (800) 437-1171.

    Distribution

    Worldwide Distribution: Nationwide distribution including the states of AZ, CA, CT, DC, FL, ID, IL, KY, LA, MD, MI, MN, NJ, NY, OR, PA, PR, TN, TX, VA, WA, and WI; and the countries of VIETNAM, MEXICO, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, ST HELENA, SPAIN, SLOVENIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, REUNION, REPUBLIC OF CHINA, QATAR, PORTUGAL POLAND, PARAGUAY, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LUXEMBOURG, LIBYA, KUWAIT, KOREA, JAPAN, ITALY, ISRAEL, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, CZECH REPUBLIC, CROATIA, COSTA RICA, COLOMBIA, CHILE, CANADA, BELARUS, BRAZIL, BOSNIA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.

    Quantity

    697