BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    Recall: Z-1694-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1694-2013
    Event ID
    65487
    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 17, 2013
    Initiation Date
    February 28, 2013
    Classification Date
    July 11, 2013
    Termination Date
    February 21, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    Reason

    Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss

    Code Info

    Model number 10140000, serial numbers 3118, 3243 and 3309

    Distribution

    United States Nationwide Distribution in the states of ND, OH and SC.

    Quantity

    3