BEUDAMED
    FDA Recall Terminated

    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging

    Recall: Z-0121-2014 · Initiated August 5, 2013

    Recall

    Recall Number
    Z-0121-2014
    Event Number
    66059
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 5, 2013
    Posted
    October 30, 2013
    Terminated
    June 28, 2016
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging

    Reason

    The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly

    Action

    Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to [email protected] Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.

    Distribution

    Nationwide Distribution including and US Territory Puerto Rico

    Quantity

    427 units (1352 total)