FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Definition Flash system, x-ray, tomography, computed
- Recall number
- Z-0374-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Definition Flash system, x-ray, tomography, computed
- Status
- Terminated
- Initiated
- 2016-10-19
- Posted
- 2016-11-08
- Terminated
- 2017-03-13
- Reason
- Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471.
- Quantity
- 57 systems distributed in USA
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Model Numbers: 8098027 10430603
- 510(k) numbers
- ["K143416"]
- PMA numbers
- not on file
- Product code
- JAK
- 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