Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
FDA Recall Z-1694-2013 · Posted 2013-07-11
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUE
Date Initiated2013-02-28
Date Terminated2014-02-21
Product Quantity3
Reason for Recall
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
United States Nationwide Distribution in the states of ND, OH and SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.