BEUDAMED
    FDA Recall Terminated

    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

    Recall: Z-2054-2009 · Initiated May 12, 2008

    Recall

    Recall Number
    Z-2054-2009
    Event Number
    52434
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 12, 2008
    Posted
    September 9, 2009
    Terminated
    July 20, 2011
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087

    Description

    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

    Reason

    The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.

    Action

    HMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.

    Distribution

    The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.

    Quantity

    10 units