BEUDAMED
    FDA Recall Terminated

    Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.

    Recall: Z-1922-2010 · Initiated June 3, 2010

    Recall

    Recall Number
    Z-1922-2010
    Event Number
    55552
    Firm
    Ge Healthcare, Llc
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2010
    Posted
    June 29, 2010
    Terminated
    September 28, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.

    Reason

    GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.

    Action

    Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.

    Quantity

    13