BEUDAMED
    FDA Enforcement Class II Terminated

    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.

    Recall: Z-0597-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0597-2016
    Event ID
    72751
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 18, 2015
    Classification Date
    January 6, 2016
    Termination Date
    December 5, 2016
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.

    Reason

    Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.

    Code Info

    Software Version: SW VD-10E

    Distribution

    Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.

    Quantity

    73 units