ARTIS One Angiographic X-Ray System
This recall is currently active, issued January 29, 2025. It was issued by Siemens Medical Solutions Usa, Inc.
- Recall Initiated
- January 2, 2025
- Posted
- January 29, 2025
- Recall Number
- Z-0922-2025
- Quantity
- 1140
- Firm Location
- Malvern Germany
- Official Source
- View on FDA website ↗
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.
Distribution
23 Distributed in the US
Lot / Code Info
Model Number 10848600
Root Cause
Radiation Control for Health and Safety Act