FDA Medical devices recall ·
ARTIS One Angiographic X-Ray System recall
- Recall number
- Z-0922-2025
- Date
- (initiated January 2, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1140
Read the official FDA notice ↗
Product
ARTIS One Angiographic X-Ray System
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number 10848600
Distribution
23 Distributed in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0922-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.