Class II — Potential Health Hazard

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

Phillips Azurion 7 M20 Recalled by Philips North America, LLC Due to No torque was specified for the four screws...

Date: March 5, 2020
Company: Philips North America, LLC
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 Philips North America, LLC directly.

Affected Products

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.

Quantity: 162 units

Why Was This Recalled?

No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America, LLC

Philips North America, LLC has 88 total recalls tracked by RecallDetector.

Related Recalls

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