BEUDAMED
    FDA Enforcement Class II Terminated

    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

    Recall: Z-2392-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2392-2016
    Event ID
    74714
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 30, 2015
    Classification Date
    August 11, 2016
    Termination Date
    November 1, 2016
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371, United States

    Description

    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

    Reason

    The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.

    Code Info

    Serial #'s: S5002-S5014; S5017-S5038

    Distribution

    US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.

    Quantity

    33 units