ARTIS One Angiographic X-Ray System — Class II medical device recall Z-0922-2025
Ongoing recall by SIEMENS MEDICAL SOLUTIONS USA, INC, reported 2025-02-05. A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release foll
| Recall number | Z-0922-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC, Malvern, Germany |
| Recall initiated | 2025-01-02 |
| Classified | 2025-01-28 |
| Reported by FDA | 2025-02-05 |
| Quantity | 1,140 |
| Model numbers | 10848600 |
Product
ARTIS One Angiographic X-Ray System
Reason for recall
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
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-0922-2025. 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.