Reported Feb 5, 2025 · Ongoing
ARTIS One Angiographic X-Ray System
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIEMENS MEDICAL SOLUTIONS USA, INC · 40 Liberty Blvd · Malvern · N/A
Is this the product you have?
- ARTIS One Angiographic X-Ray System
- Lot codes and dates
- Model Number 10848600
- Amount recalled
- 1140
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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