BEUDAMED
    FDA Recall Terminated

    Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.

    Recall: Z-0937-04 · Initiated May 6, 2004

    Recall

    Recall Number
    Z-0937-04
    Event Number
    29020
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2004
    Posted
    July 20, 2004
    Terminated
    March 15, 2005
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.

    Reason

    Software anomaly.

    Action

    Firm will send letters followed by visits to install software repair.

    Distribution

    Nationwide.

    Quantity

    50