BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1694-2013 · Initiated February 28, 2013

    Recall

    Recall Number
    Z-1694-2013
    Event Number
    65487
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 28, 2013
    Posted
    July 11, 2013
    Terminated
    February 21, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    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

    Action

    Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.

    Distribution

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

    Quantity

    3