Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Siemens ARTIS pheno Recalled by Siemens Medical Solutions USA, Inc Due to The potential exists for system movement to be...

Date: December 20, 2019
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

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Quantity: 6

Why Was This Recalled?

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

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.

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