BEUDAMED
    FDA Enforcement Class II 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 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1118-2017
    Event ID
    76273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    January 31, 2017
    Termination Date
    November 29, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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

    Code Info

    Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560 6524 6412 6442 5018 6675 8038 6575 6045 3122 6871 3243 4571 6259 6469 6676 6474 6640 6452 6561 6801 2098 4161 6483 6344 6288 6594 8002 6610 6394 4018 6502 6080 4214 6893 6093 3118 6601 5042 6246 3088 4525 6870

    Distribution

    United States Nationwide Distribution

    Quantity

    55 units