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 zee floor Recalled by Siemens Medical Solutions USA, Inc Due to Some electronic components within the generator were equipped...

Date: October 21, 2020
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 zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Quantity: 26 distributed worldwide (4 in US)

Why Was This Recalled?

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

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