HIGH

Philips Respironics Trilogy Evo Ventilators Recalled for Tidal-Volume Mismatch (113,717 Units, 2026)

Philips Respironics recalled 113,717 Trilogy Evo ventilators worldwide on March 2, 2026. The recall concerns software Version 1.05.15.00 and the use of non-pneumatic nebulizers with the Trilogy Evo platform. Hospitals and patients should stop using the device immediately and follow recall instructions from Philips Respironics or their healthcare provider.

Quick Facts at a Glance

Recall Date
March 2, 2026
Hazard Level
HIGH
Brand
Philips Respironics
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Respironics, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Trilogy Evo is a patient-ventilator used at home or in clinical settings to support breathing. It can be used with aerosol therapies via nebulizers.

Why This Is Dangerous

The use of non-pneumatic nebulizers with Trilogy Evo may cause the ventilator to deliver a tidal volume that does not match the configured setting, potentially compromising patient ventilation.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

The issue presents a high-risk safety concern for users relying on ventilator support. Immediate action is required to prevent potential under- or over-ventilation.

Practical Guidance

How to identify if yours is affected

  1. Verify software version 1.05.15.00 on the Trilogy Evo unit
  2. Confirm if non-pneumatic nebulizers were used with the device
  3. Check if the device is part of the recalled units (model numbers listed as All Model No./All UDI/All Serial No.)

Where to find product info

Recall notifications from Philips Respironics and the FDA enforcement page. Official instructions will be provided to patients and healthcare providers.

What timeline to expect

Remedies and replacement options will be communicated by Philips Respironics through official channels. Specific timelines are not provided in the raw

If the manufacturer is unresponsive

  • Escalate to hospital risk management or biosafety officer
  • File a report with the FDA if advised by healthcare provider
  • Seek assistance from the facility’s biomedical engineering department

How to prevent similar issues

  • Avoid using non-pneumatic nebulizers with Trilogy Evo devices unless specifically approved
  • Keep software updated according to manufacturer instructions
  • If purchasing a ventilator, verify compatibility with prescribed therapies and consult your clinician
  • Only follow recall instructions issued by Philips Respironics or your healthcare provider

Documentation advice

Retain the recall notification letter, document serial numbers, model numbers, software version, and all correspondences with Philips Respironics or healthcare providers.

Product Details

Brand: Philips Respironics Product: Trilogy Evo ventilator Software version: 1.05.15.00 Model numbers: All Model No., All UDI, All Serial No. Sold worldwide to healthcare providers; US nationwide and international distribution to numerous countries Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 113,717 units recalled
  • Software version 1.05.15.00
  • Worldwide distribution; US nationwide
  • Non-pneumatic nebulizers linked to the issue
  • Recall date 2026-03-02
  • Status: ACTIVE
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeContinuous Home-Use Ventilator
Sold At
Unknown

Product Details

Model Numbers
All Model No.
All UDI
All Serial No.
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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