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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Philips Respironics Trilogy Evo Ventilators Recalled for Alarm Delay

Agency Publication Date: April 2, 2026
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Summary

Philips Respironics is recalling 113,717 Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal ventilators because the Obstruction Alarm may not trigger within the required timeframe. In some cases, it can take up to four breaths for the device to notify a user of a blockage. These devices are continuous home-use ventilators used to provide respiratory support for patients. No injuries have been reported, but a delay in alarming for a blocked airway could lead to serious respiratory distress.

Risk

The software error prevents the obstruction alarm from firing immediately, potentially delaying medical intervention during a critical airway blockage. This could result in decreased oxygen levels or other life-threatening complications for patients dependent on the device.

What You Should Do

  1. Identify if you have a Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, or Trilogy Evo Universal ventilator with Software Version 1.05.15.00.
  2. Check the software version on your device settings and verify if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Philips Respironics or your Durable Medical Equipment (DME) provider to arrange for a software update, repair, or replacement.
  4. For further instructions, contact your healthcare provider or Philips Respironics directly.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips Respironics Trilogy Evo
Variants: Software Version 1.05.15.00
Serial Numbers:
All Serial No.
UDI:
All UDI

Recall #: Z-1646-2026; Quantity: 113,717 units (total across all models)

Product: Philips Respironics Trilogy Evo O2
Variants: Software Version 1.05.15.00
Serial Numbers:
All Serial No.
UDI:
All UDI

Recall #: Z-1647-2026

Product: Philips Respironics Trilogy EV300
Variants: Software Version 1.05.15.00
Serial Numbers:
All Serial No.
UDI:
All UDI

Recall #: Z-1648-2026

Product: Philips Respironics Trilogy Evo Universal
Variants: Software Version 1.05.15.00
Serial Numbers:
All Serial No.
UDI:
All UDI

Recall #: Z-1649-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98540
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Durable Medical Equipment (DME) providers; Hospitals; Home healthcare distributors
Manufactured In: United States
Units Affected: 4 products (113,717 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.