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 Recalled by Siemens Medical Solutions USA, Inc Due to During manual LAO/RAO rotation at maximum speed or...

Date: May 30, 2018
Company: Siemens Medical Solutions USA, Inc
Status: Terminated
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, Fluoroscopic X-Ray system, Model Number 10849000

Quantity: 40 in the United States

Why Was This Recalled?

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

Where Was This Sold?

This product was distributed to 18 states: AL, CA, CO, FL, IL, KY, ME, MA, MI, MN, MS, 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