BEUDAMED
    FDA Recall Terminated

    Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

    Recall: Z-1005-04 · Initiated May 7, 2004

    Recall

    Recall Number
    Z-1005-04
    Event Number
    29160
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 7, 2004
    Posted
    July 20, 2004
    Terminated
    November 1, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

    Reason

    Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.

    Action

    The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.

    Distribution

    The devices were shipped to consignees in OH, PA, WI.

    Quantity

    3 units