BEUDAMED
    FDA Recall Terminated

    syngo.plaza Image processing system

    Recall: Z-0522-2012 · Initiated September 21, 2011

    Recall

    Recall Number
    Z-0522-2012
    Event Number
    60426
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 21, 2011
    Posted
    January 11, 2012
    Terminated
    January 31, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    syngo.plaza Image processing system

    Reason

    Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.

    Action

    Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.

    Distribution

    Nationwide Distribution New York

    Quantity

    1