Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARTIS One Angiographic X-Ray System Recalled by SIEMENS MEDICAL SOLUTIONS USA, INC Due to A potential issue with ARTIS One systems was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SIEMENS MEDICAL SOLUTIONS USA, INC directly.
Affected Products
ARTIS One Angiographic X-Ray System
Quantity: 1140
Why Was This 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.
Where Was This Sold?
23 Distributed in the US
About SIEMENS MEDICAL SOLUTIONS USA, INC
SIEMENS MEDICAL SOLUTIONS USA, INC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report