Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Recalled by Siemens Medical Solutions USA, Inc Due to Potential exists for one or more axes of...
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 Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Quantity: 96 US
Why Was This Recalled?
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report