Class IIReported 2026-02-11
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Recalled by Siemens Medical Solutions USA, Inc
Reason for Recall
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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Recall NumberZ-1239-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2025-12-19Reported2026-02-11DistributionWorldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.Code InfoMaterial Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.