Recall Z-0922-2025 ยท OWB Interventional Fluoroscopic X-Ray System
SIEMENS MEDICAL SOLUTIONS USA, INC
ARTIS One Angiographic X-Ray System
| Date | Jan 29, 2025 (initiated Jan 2, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Quantity | 1140 |
| Distribution | 23 Distributed in the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc., Apr 28, 2014 |