BEUDAMED
    FDA Recall Terminated

    syngo Imaging XS. Radiological image processing system.

    Recall: Z-2264-2012 · Initiated July 18, 2012

    Recall

    Recall Number
    Z-2264-2012
    Event Number
    62678
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 18, 2012
    Posted
    August 24, 2012
    Terminated
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    syngo Imaging XS. Radiological image processing system.

    Reason

    There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".

    Action

    Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..

    Distribution

    Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

    Quantity

    52