BEUDAMED
    FDA Recall Terminated

    AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems

    Recall: Z-1104-06 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-1104-06
    Event Number
    35100
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    June 10, 2006
    Terminated
    November 24, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems

    Reason

    Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.

    Action

    The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.

    Distribution

    The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas

    Quantity

    5