FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
- Recall number
- Z-2625-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
- Status
- Terminated
- Initiated
- 2016-07-13
- Posted
- 2016-08-23
- Terminated
- 2017-01-24
- Reason
- Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
- Root cause
- Software in the Use Environment
- Action
- Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.
- Quantity
- 2 systems
- Distribution
- Distributed to: MI, NY, CA, KY, ND, NE
- Lot, serial or model codes
- Model # 10590000 Serial # 83398, and 83387
- 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