ARTIS One Angiographic X-Ray System recall
ARTIS One Angiographic X-Ray System
Why was ARTIS One Angiographic X-Ray System 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 10848600
- Product
- ARTIS One Angiographic X-Ray System
- Recalling firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Quantity
- 1140
- Distribution
- 23 Distributed in the US
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)