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Medical Device

NAEOTOM Alpha 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 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
88 units
Description
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
View official recall notice →