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Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT AS
Recalled February 11, 2026 · FDA recall Z-1241-2026 · Siemens Medical Solutions USA
Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. · FDA Class II
Units
5 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Description
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →