BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0597-2016 · Initiated November 18, 2015

    Recall

    Recall Number
    Z-0597-2016
    Event Number
    72751
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 18, 2015
    Posted
    January 6, 2016
    Terminated
    December 5, 2016
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens sent an Important Customer Safety Notice dated November 17, 2015. The Notice identified the product, the problem, and the action to be taken by the customer. The potential issue will be remedied with a software update via Update Instructions AX067/15/S. Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers with questions were advised to call 800-888-7436.

    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