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FDADecember 19, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

siemens medical solutionssiemenssiemens medical

UPCs

04056869263168

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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