Class II — Potential Health Hazard

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

Zenition 50 & 70 Mobile Surgery C-arm Recalled by Philips North America Due to Philips has become aware of an issue with...

Date: October 4, 2023
Company: Philips North America
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 Philips North America directly.

Affected Products

Zenition 50 & 70 Mobile Surgery C-arm

Why Was This Recalled?

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Where Was This Sold?

United States Territories of Puerto Rico, Guam, and Virgin Islands

About Philips North America

Philips North America has 107 total recalls tracked by RecallDetector.

Related Recalls

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