ARTIS One Angiographic X-Ray System
FDA device recall Z-0922-2025 · posted 2025-01-29 · Open, Classified
Recall details
- Recalling firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 1140
- Distribution
- 23 Distributed in the US
- Date initiated
- 2025-01-02
- Date posted
- 2025-01-29
- Location
- Malvern, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ONE (K133580) | Siemens Medical Solutions USA, Inc. | 2014-04-28 |