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Siemens Medical Solutions USA, Inc: NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Medical DevicesSource: FDA (device) · Date: 2026-02-11

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Medical Solutions USA, Inc
Product
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Reason / hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Recall initiated
2025-12-19
Code info
Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Malvern
State
PA
Country
United States
Event id
98206
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