Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities Recalled by Siemens Medical Solutions USA, Inc Due to To remove the software applications from certain CT...
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
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Quantity: 2 units
Why Was This Recalled?
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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