BEUDAMED
    FDA Recall 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 · Initiated June 6, 2016

    Recall

    Recall Number
    Z-2107-2016
    Event Number
    74422
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2016
    Terminated
    January 17, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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).

    Action

    Siemens mailed customers a letter to inform them about improvements that were made to the SYNGO Breast Care reading software to correct certain behaviors that were being seen during use. Customers were asked to upgrade their systems to this new version.

    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