ARTIS pheno and ARTIS Icono biplane — Class II medical device recall Z-1653-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-04-15, distributed nationwide. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to
| Recall number | Z-1653-2026 |
|---|---|
| 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 | 2026-03-10 |
| Classified | 2026-04-07 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04056869046877, 04056869063317, 04056869149325, 04056869295923 |
| Model numbers | 10849000, 11327600, 11327700, 11328100 |
Product
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Reason for recall
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
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-1653-2026. 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.