BEUDAMED
    FDA Recall Terminated

    Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license

    Recall: Z-0174-2010 · Initiated September 30, 2009

    Recall

    Recall Number
    Z-0174-2010
    Event Number
    53564
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 30, 2009
    Posted
    November 10, 2009
    Terminated
    July 5, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license

    Reason

    Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.

    Action

    The recalling firm issued a "Customer Safety Advisory Notice" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center.

    Distribution

    The product was shipped to medical facilities in NY and OH

    Quantity

    2 units