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 Icono Recalled by Siemens Medical Solutions USA, Inc Due to During system tests, an increased wearing of the...

Date: May 20, 2022
Company: Siemens Medical Solutions USA, Inc
Status: Ongoing
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 Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

Quantity: 195 worldwide, 88 US

Why Was This Recalled?

During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

Where Was This Sold?

This product was distributed to 32 states: AL, AZ, AR, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MD, MA, MI, MO, MT, NE, NJ, NY, NC, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI

Affected (32 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