BEUDAMED
    FDA Recall Terminated

    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

    Recall: Z-0305-2008 · Initiated October 2, 2007

    Recall

    Recall Number
    Z-0305-2008
    Event Number
    45811
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 2, 2007
    Posted
    January 9, 2008
    Terminated
    April 20, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

    Reason

    Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.

    Action

    Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions"

    Distribution

    Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV

    Quantity

    69