ARTIS pheno — Class II medical device recall Z-2205-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-06-10. During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. T
| Recall number | Z-2205-2026 |
|---|---|
| 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 | 2026-03-09 |
| Classified | 2026-06-04 |
| Reported by FDA | 2026-06-10 |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Model numbers | 10849000 |
Product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Reason for recall
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the 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-2205-2026. 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.