BEUDAMED
    FDA Recall Terminated

    Siemens syngo.plaza. Radiological image processing system

    Recall: Z-2078-2012 · Initiated February 24, 2012

    Recall

    Recall Number
    Z-2078-2012
    Event Number
    62462
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 24, 2012
    Posted
    July 26, 2012
    Terminated
    January 14, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens syngo.plaza. Radiological image processing system

    Reason

    Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

    Action

    Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.

    Distribution

    (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

    Quantity

    2