BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2392-2016 · Initiated June 30, 2015

    Recall

    Recall Number
    Z-2392-2016
    Event Number
    74714
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 30, 2015
    Terminated
    November 1, 2016
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    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.

    Action

    Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.

    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