Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SOMATOM Definition Edge with software version VA48A-SP2 Recalled by Siemens Medical Solutions USA, Inc Due to Due to an internal communication error between the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc directly.
Affected Products
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Quantity: 4 systems
Why Was This 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.
Where Was This Sold?
This product was distributed to 6 states: CA, KY, MI, NE, NY, ND
About Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report