Class II — SIEMENS MEDICAL SOLUTIONS USA, INC
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | ARTIS One Angiographic X-Ray System |
| Quantity | 1140 |
| Distribution | 23 Distributed in the US |
| Initiated | 2025-01-02 |
| Classified | 2025-01-28 |
| Recall number | Z-0922-2025 |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SIEMENS MEDICAL SOLUTIONS USA, INC (Z-0922-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96088/
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