ARTIS Pheno VE30A and VE40A — Class II medical device recall Z-1814-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-04-22. During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3
| Recall number | Z-1814-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2026-03-12 |
| Classified | 2026-04-16 |
| Reported by FDA | 2026-04-22 |
| Quantity | 73 |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Model numbers | 10849000 |
Product
ARTIS Pheno VE30A and VE40A, Model 10849000
Reason for recall
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
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-1814-2026. 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.