BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

    Recall: Z-1975-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1975-2013
    Event ID
    65719
    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 21, 2013
    Initiation Date
    March 4, 2013
    Classification Date
    August 15, 2013
    Termination Date
    March 9, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

    Reason

    Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

    Code Info

    Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.

    Distribution

    Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.

    Quantity

    6