Recall Z-1694-2013 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
| Date | Jul 11, 2013 (initiated Feb 28, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| 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. |
| Quantity | 3 |
| Distribution | United States Nationwide Distribution in the states of ND, OH and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122286 | MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc., Feb 22, 2013 |