BEUDAMED
    FDA Recall Terminated

    MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.

    Recall: Z-0029-2007 · Initiated August 16, 2006

    Recall

    Recall Number
    Z-0029-2007
    Event Number
    36224
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 16, 2006
    Posted
    October 12, 2006
    Terminated
    April 13, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.

    Reason

    Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

    Action

    On 8/16/2006, Hitachi issued two (2) Device Correction letters. The first letter was addressed to the five (5) customers whose system units are currently ''de-installed''. This letter informs the customers of the problem and asks that the customer(s) please contact the firm''s Customer Service Center on their toll-free tel. # 1-800-800-4925, in order to schedule a device correction should the customer ever re-activate/install their system(s). The second letter, issued to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the problem, and states that a HMSA Service (person) will be contacting the customer in order to schedule a device correction which should address the problem.

    Distribution

    Nationwide and Puerto Rico.

    Quantity

    348 units