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 Recalled by Siemens Medical Solutions USA, Inc Due to If the C-arm is manually moved in the...
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 10849000
Quantity: 39
Why Was This Recalled?
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Where Was This Sold?
This product was distributed to 18 states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, VA
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