BEUDAMED
    FDA Recall Terminated

    Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002

    Recall: Z-0982-05 · Initiated May 23, 2005

    Recall

    Recall Number
    Z-0982-05
    Event Number
    32387
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2005
    Posted
    July 13, 2005
    Terminated
    May 10, 2012
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002

    Reason

    If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values.

    Action

    Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits.

    Distribution

    Nationwide. This is an imported product.

    Quantity

    106