BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    Recall: Z-1981-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1981-2015
    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 530. 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 Not Available 702731CATH3 0000013C2R0003 6012883100CV4 15C2R0084 702880CATH2 15C2R0086 GON4300165 15C2R0085 918787530 15C2R0087 814877EP 0000015C2R0091 GON1441141 0000014C2R0188 XV650620BU8 0000015C2R0083 GON1487269 0000015C2R0088 GON4271086 0000015C2R0064 080041RX18 15C2R0055 414649IGS2 15C2R0072 GON4211904 0000015C2R0074 0004077351 0000015C2R0066 082416190029 0000015C2R0070 082416100092 0000015C2R0071 082416190026

    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

    17