NAEOTOM Alpha — Class II medical device recall Z-1242-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-02-11, distributed nationwide. To remove the software applications from certain CT systems as the applications have not received FDA 510(k) c
| Recall number | Z-1242-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-02-03 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CR, IL, IN |
| Quantity | 2 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04068151014655 |
| Serial numbers | 258043, 258055 |
Product
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Reason for recall
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1242-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.