Class II — Potential Health Hazard

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...

Date: May 1, 2018
Company: Siemens Medical Solutions USA, Inc
Status: Completed
Source: FDA (Device)

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

Affected (18 states)Not affected

About Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report