BEUDAMED
    FDA Recall Terminated

    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

    Recall: Z-1104-2013 · Initiated December 11, 2012

    Recall

    Recall Number
    Z-1104-2013
    Event Number
    64693
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 11, 2012
    Posted
    April 12, 2013
    Terminated
    April 10, 2014
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92780-7047

    Description

    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

    Reason

    Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.

    Action

    Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter.

    Distribution

    Nationwide Distribution.

    Quantity

    233 units