BEUDAMED
    FDA Recall Terminated

    NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

    Recall: Z-0253-2008 · Initiated August 29, 2007

    Recall

    Recall Number
    Z-0253-2008
    Event Number
    44811
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 29, 2007
    Posted
    November 17, 2007
    Terminated
    April 5, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

    Reason

    Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

    Action

    Urgent Medical Device Notification letters were sent to customers on August 29, 2007. Customers were notified of the several issues related to the Nemio SSA-550A and Nemio SSA-580A recall and asked to share this information with all users of the device. Customers were informed that Toshiba is preparing software and corrected manuals for distribution to address these issues. 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.

    Distribution

    Nationwide

    Quantity

    1,278 units