Z-0922-2025 Class II Ongoing
FDA device recall Z-0922-2025 was initiated by SIEMENS MEDICAL SOLUTIONS USA, INC on January 2, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1140.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- January 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Product Quantity
- 1140
Product Description
ARTIS One Angiographic X-Ray System
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 Pattern
23 Distributed in the US
Code Information
Model Number 10848600