Class II — Potential Health Hazard

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

Azurion FlexArm Recalled by Philips North America, LLC Due to During manufacturing of an Azurion R2.0 system, it...

Date: March 12, 2019
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

Azurion FlexArm, 722079

Quantity: 2

Why Was This Recalled?

During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

Where Was This Sold?

Distributed to one account in Florida, and one international account in Germany.

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