BEUDAMED
    FDA Enforcement Class II Terminated

    XARIO 200 TUS-X200 diagnostic ultrasound system

    Recall: Z-2709-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2709-2017
    Event ID
    77599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    May 1, 2017
    Classification Date
    July 10, 2017
    Termination Date
    October 11, 2023
    Address
    PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    XARIO 200 TUS-X200 diagnostic ultrasound system

    Reason

    When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

    Code Info

    Serial Number W5B1712472

    Distribution

    Nationwide Distribution

    Quantity

    1 unit