BEUDAMED
    FDA Recall Terminated

    Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software

    Recall: Z-0986-2007 · Initiated February 2, 2007

    Recall

    Recall Number
    Z-0986-2007
    Event Number
    37965
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2007
    Posted
    June 27, 2007
    Terminated
    April 18, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software

    Reason

    When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.

    Action

    Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

    Distribution

    Nationwide

    Quantity

    45