BEUDAMED
    FDA Recall Terminated

    syngo Imaging XS, all versions Radiological image processing system

    Recall: Z-0514-2012 · Initiated September 20, 2011

    Recall

    Recall Number
    Z-0514-2012
    Event Number
    60425
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 20, 2011
    Posted
    January 11, 2012
    Terminated
    March 5, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    syngo Imaging XS, all versions Radiological image processing system

    Reason

    Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.

    Action

    Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.

    Distribution

    Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

    Quantity

    38