FDA-Device2026-02-11Class IIMISBRANDING
Siemens NAEOTOM Alpha.Prime CT system software recalled for lack of FDA clearance
FALSE CLAIMSNationwide distribution
Remove Siemens NAEOTOM software applications
Siemens Medical Solutions distributed five CT imaging systems with three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) that did not receive required FDA 510(k) clearance before use. No injuries have been reported.
- Contact your Siemens service representative immediately if your facility operates one of the five affected systems (serial numbers: 183046, 183047, 183048, 183050, 183051)
- Stop using the three software applications until they are removed from the system
- Do not use patient results from these applications for clinical decision-making
Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Affected count
5 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2026More Siemens Medical Solutions USA, Inc recalls
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