What is being recalled?

The Philips Respironics Trilogy Evo O2 home-use ventilator with software version 1.05.15.00 is being recalled due to a potential obstruction alarm failure.

How many units are affected?

113,717 units worldwide are included in the recall.

Why is the recall necessary?

The Obstruction Alarm may not trigger within the required timeframe, delaying warning after airway obstruction for up to four breaths.

Anyone using a Trilogy Evo O2 ventilator with the specified software version.

What should I do now?

Stop using the device and follow the recall instructions. Contact Philips Respironics or your clinician for guidance.

Have there been any injuries reported?

No injuries or incidents have been reported in the recall materials.

How can I check if my device is affected?

Verify the device software version. If it shows 1.05.15.00, it is within the recall scope.

What if my clinician says the device is essential?

Discuss risks with your clinician. The recall requires interim stop-use and guidance from the manufacturer and clinician.

Will I get a replacement or refund?

Details are provided in the recall letter from Philips Respironics. Contact the company for remedies.

How long will the remedy take?

Remedy timelines vary; recall communications typically outline processing times (often several weeks to a couple of months).

Is this recall limited to the United States?

Distribution is nationwide in the U.S. and includes many countries internationally.

Where can I find the official recall notice?

Refer to the FDA enforcement page for Z-1647-2026 and Philips recall communications.

HIGHMarch 2, 2026

Philips Respironics Trilogy Evo O2 Ventilator Recall Affects 113,717 Units in 2026

Philips Respironics recalls 113,717 Trilogy Evo O2 home-use ventilators in 2026. The Obstruction Alarm may fail to trigger within required standards, delaying warning for airway obstruction for up to four breaths. Stop using the device and follow recall instructions from Philips or your clinician.

Quick Facts at a Glance

Recall Date: March 2, 2026
Hazard Level: HIGH
AI Risk Assessment: CRITICAL
Brand: Philips Respironics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

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 O2 is a home-use ventilator providing respiratory support for patients with chronic respiratory insufficiency. It is marketed for ongoing daily use under clinician supervision.

Why This Is Dangerous

A delay in triggering the obstruction alarm can leave a patient without timely warning of airway obstruction. This can prolong unsafe breathing conditions and pose a risk to life if not addressed.

Industry Context

This recall is not indicated as part of a broader industry pattern.

Real-World Impact

Patients and caregivers must stop using the affected devices until advised. The interruption of ventilation support can have serious safety and health consequences and may require medical supervision and alternative arrangements.

Practical Guidance

How to identify if yours is affected

Confirm device is Trilogy Evo O2 with software version 1.05.15.00.
Check device label or system menu for software version.
Cross-check with the recall notice and FDA page (Z-1647-2026).

Where to find product info

Recall letter, Philips Respironics patient guidance, and FDA enforcement page provided above.

What timeline to expect

Remedy processing and replacement or guidance typically take 4-8 weeks, depending on the program.

If the manufacturer is unresponsive

Escalate with your healthcare provider, contact Philips Respironics consumer support, and file a complaint with the U.S. FDA if necessary.
Document all communications and keep the recall letter for reference.

How to prevent similar issues

Regularly check software updates from the manufacturer.
Only operate ventilators under clinician guidance.
Maintain backup ventilation plans and power sources.
Ensure contact information for Philips Respironics is current for recall alerts.

Documentation advice

Keep the recall letter, purchase records, device serial number and model information, and any correspondence with Philips Respironics or healthcare providers.

Product Details

Product: Philips Respironics Trilogy Evo O2 home-use ventilator. Software version: 1.05.15.00. Recall quantity: 113,717 units. Model numbers: All Model No., All UDI, All Serial No. Sold nationwide in the United States and distributed internationally to many countries (Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, and more). Recall date: 2026-03-02. Recall status: Active.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

113,717 units recalled worldwide
Software Version 1.05.15.00 involved
Obstruction Alarm delay up to four breaths
Domestic nationwide distribution; broad international outreach
Recall date 2026-03-02; Status Active

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelCRITICAL

Severity Score

10/ 10

Affected Groups

GENERAL

Injury Types

SUFFOCATION

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeHome-use Ventilator

Product Details

Brand

Philips Respironics

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