BEUDAMED
    FDA Enforcement Class II Terminated

    Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

    Recall: Z-0119-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0119-2014
    Event ID
    66059
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    August 5, 2013
    Classification Date
    October 30, 2013
    Termination Date
    June 28, 2016
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    Description

    Xario Diagnostic Ultrasound System SSA-660A 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

    Code Info

    Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613

    Distribution

    Nationwide Distribution including and US Territory Puerto Rico

    Quantity

    17 (1352 Total)