FDA Enforcement
Class II
Ongoing
ARTIS One Angiographic X-Ray System
Recall: Z-0922-2025
·
Reported February 5, 2025
Enforcement
- Recall Number
- Z-0922-2025
- Event ID
- 96088
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Initial Notification
- Letter
- Report Date
- February 5, 2025
- Initiation Date
- January 2, 2025
- Classification Date
- January 28, 2025
- Address
- 40 Liberty Blvd, Malvern, N/A, 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.
Code Info
Model Number 10848600
Distribution
23 Distributed in the US
Quantity
1140