HIGH

Philips Respironics Trilogy EV300 Recalled 113,717 Units Worldwide for Tidal Volume Discrepancy (202

Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold worldwide through healthcare distributors on March 2, 2026. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may cause a mismatch between the set tidal volume and the delivered tidal volume. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the 제조

Quick Facts at a Glance

Recall Date
March 2, 2026
Hazard Level
HIGH
Brand
Philips Respironics
Category
Health & Personal Care
Sold At
Multiple Retailers
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 EV300 is a continuous home-use ventilator intended to support patients with respiratory failure. It is used under medical supervision, often in home settings or during non-acute care.

Why This Is Dangerous

Using non-pneumatic nebulizers with the Trilogy Evo Platform can cause a mismatch between the set and delivered tidal volumes, potentially compromising ventilation and patient safety.

Industry Context

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

Real-World Impact

Hospitals and home-care patients may face interruptions in supply or require urgent device replacements, creating safety and care continuity concerns.

Practical Guidance

How to identify if yours is affected

  1. Verify device is Trilogy EV300.
  2. Check software version 1.05.15.00 on the device label or system menu.
  3. Confirm use of non-pneumatic nebulizers with the Evo Platform.

Where to find product info

Recall notices available via FDA enforcement page and Philips Respironics recall communications to healthcare providers.

What timeline to expect

Remedy timelines are not specified in the recall notice.

If the manufacturer is unresponsive

  • Escalate to regulatory authorities (FDA) if the manufacturer is slow to respond.
  • Document all communications and keep the recall letter or notice.

How to prevent similar issues

  • Use only compatible nebulizers specified by Philips.
  • Consult healthcare providers before changing nebulizer equipment.
  • Monitor patient ventilation and report any unusual symptoms immediately.

Documentation advice

Keep recall letter, model numbers, software version, dates of service, and all correspondence with Philips or healthcare providers.

Product Details

Model numbers: All Model No., All UDI, All Serial No. Where sold: Worldwide distribution through healthcare distributors When sold: Unknown Price: Unknown (price range not disclosed)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 113,717 units recalled
  • Software Version 1.05.15.00
  • Non-pneumatic nebulizers implicated
  • Tidal volume discrepancy risk
  • Worldwide distribution (US and foreign)
  • Active recall as of 2026-03-02

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 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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