BEUDAMED
    FDA Recall Terminated

    GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.

    Recall: Z-1689-2009 · Initiated October 9, 2008

    Recall

    Recall Number
    Z-1689-2009
    Event Number
    53260
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 9, 2008
    Posted
    September 24, 2009
    Terminated
    January 7, 2012
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.

    Reason

    GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equival

    Action

    Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.

    Distribution

    Nationwide Distribution -- United States including Puerto Rico and Guam.

    Quantity

    929 units total