FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
- Recall number
- Z-1694-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
- Status
- Terminated
- Initiated
- 2013-02-28
- Posted
- 2013-07-11
- Terminated
- 2014-02-21
- 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.
- Lot, serial or model codes
- Model number 10140000, serial numbers 3118, 3243 and 3309
- 510(k) numbers
- ["K122286"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28