BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    Recall: Z-1980-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1980-2015
    Event ID
    71508
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    July 2, 2015
    Termination Date
    October 28, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    Reason

    GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

    Code Info

    Serial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026 0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02

    Distribution

    Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.

    Quantity

    10