Device product
ARTIS One Angiographic X-Ray System
Z-0922-2025
Product summary
- Event
- Event 96088
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1140
- Official record key
device-enforcement:Z-0922-2025
Official wording
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.
Code information: Model Number 10848600
Distribution pattern: 23 Distributed in the US
Derived failure modes
-
Unknown
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.