Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
FDA device recall Z-1694-2013 · posted 2013-07-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 3
- Distribution
- United States Nationwide Distribution in the states of ND, OH and SC.
- Date initiated
- 2013-02-28
- Date posted
- 2013-07-11
- Date terminated
- 2014-02-21
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAMMOMAL INSPIRATION (K122286) | Siemens Medical Solutions USA, Inc. | 2013-02-22 |