BEUDAMED
    FDA Recall Terminated

    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

    Recall: Z-1118-2017 · Initiated January 11, 2017

    Recall

    Recall Number
    Z-1118-2017
    Event Number
    76273
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 11, 2017
    Terminated
    November 29, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

    Reason

    Software error

    Action

    Siemens mailed a Customer Safety Advisory Notice (CSAN) letter dated January 11, 2017 to affected customers. The letter identified the affected product, the potential risks and the steps to take to avoid the risks associated with the issue. The letter also stated Siemens will release a field modification (software update) to resolve the issue as soon as possible. The new software will be provided to affected customers free of charge.

    Distribution

    United States Nationwide Distribution

    Quantity

    55 units