--- title: "NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT V... — FDA record Z-1240-2026 | Is It on Recall" description: "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." url: https://isitonrecall.com/recall/fda-device-z-1240-2026-naeotom-alpha-software-applications-syngo-ct-brain-quantification-syngo-ct-vessel-hyperdensities-syn/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS — FDA record Z-1240-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS - **Reason**: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - **Classification**: Class II - **Recalling firm**: Siemens Medical Solutions USA, Inc - **Quantity**: 88 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1240-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1240-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169; | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1240-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Siemens Medical Solutions USA, Inc records](https://isitonrecall.com/brand/siemens-medical-solutions-usa-inc/)