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 Universal Recalled by Philips Respironics, Inc. Due to Two software issues have been identified related to...

Date: July 26, 2021
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 Universal, Product number DS2000X11B

Quantity: 10,000 (FEMA Stockpile Only)

Why Was This Recalled?

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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