Class II — Potential Health Hazard

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

Trilogy Evo Recalled by Philips Respironics, Inc. Due to There are errors present in the Korean Instructions...

Date: May 25, 2023
Company: Philips Respironics, Inc.
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 Respironics, Inc. directly.

Affected Products

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Quantity: 1,581 units

Why Was This Recalled?

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

Where Was This Sold?

Foreign Distribution: Korea.

About Philips Respironics, Inc.

Philips Respironics, Inc. has 85 total recalls tracked by RecallDetector.

Related Recalls

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