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 biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 Recalled by Siemens Medical Solutions USA, Inc Due to Siemens has become aware of a potential hardware...

Date: August 10, 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 biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

Quantity: 1,389 (590 US; 799 OUS) (Total)

Why Was This Recalled?

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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