BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    Recall: Z-1984-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1984-2015
    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 630. 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 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067

    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

    8