BEUDAMED
    FDA Enforcement Class II Terminated

    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.

    Recall: Z-2107-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2107-2016
    Event ID
    74422
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    June 6, 2016
    Classification Date
    June 30, 2016
    Termination Date
    January 17, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.

    Reason

    Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).

    Code Info

    Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575

    Distribution

    Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND

    Quantity

    29 units