BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1104-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1104-2013
    Event ID
    64693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    December 11, 2012
    Classification Date
    April 12, 2013
    Termination Date
    April 10, 2014
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    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.

    Code Info

    Item numbers: TUS-A300/Wl and TUS-A500/Wl

    Distribution

    Nationwide Distribution.

    Quantity

    233 units