FDA Recall
Open, Classified
ARTIS One Angiographic X-Ray System
Recall: Z-0922-2025
·
Initiated January 2, 2025
Recall
- Recall Number
- Z-0922-2025
- Event Number
- 96088
- Firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- FEI Number
- 3016408824
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- January 2, 2025
- Posted
- January 29, 2025
- Address
- 40 Liberty Blvd, Malvern Germany
Description
ARTIS One Angiographic X-Ray System
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.
Distribution
23 Distributed in the US
Quantity
1140