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 oneFloor-mounted system for uncompromised imaging Recalled by Siemens Medical Solutions USA, INC Due to The possibility exists for the monitor display of...

Date: August 22, 2017
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 oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

Quantity: 207 worldwide (13 distributed in US)

Why Was This Recalled?

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

Where Was This Sold?

This product was distributed to 12 states: AL, AR, CA, IN, LA, MI, MO, NY, NC, PA, TX, WA

Affected (12 states)Not affected

About Siemens Medical Solutions USA, INC

Siemens Medical Solutions USA, INC has 1 total recall tracked by RecallDetector.

Related Recalls

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