BEUDAMED
    FDA Recall Terminated

    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.

    Recall: Z-1571-2008 · Initiated February 25, 2008

    Recall

    Recall Number
    Z-1571-2008
    Event Number
    47253
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 25, 2008
    Posted
    July 24, 2008
    Terminated
    February 24, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.

    Reason

    Miscalculation reading. A software error in the firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans.

    Action

    A Device Correction Letter was issue by the firm on 02/25/2008. The letter asks the affected customers not to use the value of ICA/CCA on the Measurement Report for diagnosis, but instead to follow the Immediate countermeasure detailed in the 'Note in Use' document which accompanies the Device Correction letter. The customers are asked to follow the Immediate Countermeasure until they receive a Temporary Countermeasure to correct the ICA/CCA ratio calculation. The Temporary Countermeasure will include: 1) a Disk to import a new carotid measure package; 2) an Installation booklet detailing how to import the new carotid measurement package and optional customization tools; and 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software revision, service personnel will replace the software at each customer location.

    Distribution

    Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.

    Quantity

    20 units