FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
- Recall number
- Z-1638-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
- Status
- Terminated
- Initiated
- 2014-04-25
- Posted
- 2014-05-20
- Terminated
- 2014-12-15
- Reason
- There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
- Root cause
- Device Design
- Action
- A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
- Quantity
- 5
- Distribution
- Distributed in the states of GA, FL, NY, NV, and MA.
- Lot, serial or model codes
- (Material number 10549894) with serial numbers 5000 through 5029.
- 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