BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Mammomat Inspiration mammography systems. 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-0086-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0086-2015
    Event ID
    69371
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    September 18, 2014
    Classification Date
    October 17, 2014
    Termination Date
    February 24, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Siemens Mammomat Inspiration mammography systems. 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

    The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

    Code Info

    material #10140000, with serial numbers: 5018 3849 5042

    Distribution

    US Distribution in states of: NY, VA, and MA.

    Quantity

    3