BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.

    Recall: Z-0540-2010 · Initiated October 14, 2009

    Recall

    Recall Number
    Z-0540-2010
    Event Number
    53596
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 14, 2009
    Posted
    December 16, 2009
    Terminated
    February 4, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.

    Reason

    GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.

    Distribution

    Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHILE , CANADA and BAHRAIN.

    Quantity

    114