medical Class II Updated 2026-02-11

Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Prime Software applications: syngo.CT Brain

Recalled Product

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


Hazard / Issue

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;
View official government recall

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