BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.

    Recall: Z-1124-2012 · Initiated May 4, 2011

    Recall

    Recall Number
    Z-1124-2012
    Event Number
    59944
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 4, 2011
    Posted
    March 19, 2012
    Terminated
    March 29, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.

    Reason

    It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J).

    Action

    GE Healthcare will alert affected Innova users with a Diamentor M4-KDK unit of this issue and the workaround to mitigate this issue. GE Healthcare will bring affected Innova units in the field into compliance by enabling the Innova certified display and providing affected customers with an Operators Manual Addendum and Service Manual Addendum which will address this topic. GE Healthcare will correct all affected systems by updating the system's Operator and Service Correction manuals and enabling the innova dose display on the Live and Reference monitors and the DLconsole. The Diamentor M4-KDK can still be used to display additional informative dose values. GE Healthcare will, without charge, remedy the defect or bring the product into compliance; the details of which will be included in a subsequent communication to you or through a GE field engineer site visit. GE Healthcare updated the Innova User Instructions, as part of the recall, to indicate to meet regulatory requirements based on the international safety standards IEC 60601-2-43:2000 and/or 21 CFR 1020.30 (k), use as reference the exposure dose displayed on the DL console, live or reference monitor. If you have any further questions or concerns please call 800-437-1171.

    Distribution

    USA Nationwide Distribution

    Quantity

    19