SOMATOM Definition Flash with software version VA48A-SP2 recallZ-2625-2016 · Siemens Medical Solutions USA, Inc · initiated Jul 13, 2016
Class II Terminated All recalls posted in August 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software in the Use Environment
What the company is doing
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.
Recall details
- Recall number
- Z-2625-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 13, 2016
- Posted by the FDA
- Aug 23, 2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2 systems
- Product code
- JAK
- FDA submissions
- K143416
- Distribution
- Distributed to: MI, NY, CA, KY, ND, NE
Product description
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Code information (models, lots, serial numbers)
Model # 10590000 Serial # 83398, and 83387
Other devices under the same FDA submission
1 device cleared under K143416 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SOMATOM Definition Flash 10430603Siemens Healthcare GmbH · System, x-ray, tomography, computed1 death27 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 74840).
- Z-2626-2016 · TerminatedSOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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