BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo.plaza. Radiological image processing system

    Recall: Z-2078-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2078-2012
    Event ID
    62462
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    February 24, 2012
    Classification Date
    July 26, 2012
    Termination Date
    January 14, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    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.

    Code Info

    Model number 10592457

    Distribution

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

    Quantity

    2