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Medical Device

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Recall date: 2026-02-11 · Source: FDA_DEVICE
Brand / Firm
Siemens Medical Solutions USA, Inc
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Reason for recall
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Units affected
5 units
Description
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
View official recall notice →