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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 Trilogy Evo Ventilators Recalled for Volume Discrepancy

Agency Publication Date: March 26, 2026
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Summary

Philips Respironics is recalling approximately 454,868 Trilogy Evo platform ventilators, including the Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal models. The recall was initiated because using non-pneumatic nebulizers with these devices can cause the patient to receive a different amount of air (tidal volume) than what the ventilator is set to provide. This issue affects devices running software version 1.05.15.00 and was reported across worldwide distributions, including over 113,000 units of each model variant.

Risk

If there is a discrepancy between the set and received tidal volume, patients may receive insufficient oxygen or too much pressure, which can lead to respiratory distress or lung injury. This risk is specifically present when using non-pneumatic nebulizers with the affected software version.

What You Should Do

  1. Identify if you have a Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, or Trilogy Evo Universal ventilator by checking the model name on the front of the device.
  2. Verify if your device is running software version 1.05.15.00 by checking the software settings or system information menu on the ventilator screen.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or wish to report a problem with the device.

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-1614-2026; Quantity: 113,717 units; Continuous home-use ventilator device.

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

Recall #: Z-1615-2026; Quantity: 113,717 units; Continuous home-use ventilator device.

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

Recall #: Z-1616-2026; Quantity: 113,717 units; Continuous home-use ventilator device.

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

Recall #: Z-1617-2026; Quantity: 113,717 units; Continuous home-use ventilator device.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98537
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Medical equipment distributors; Healthcare providers
Manufactured In: United States
Units Affected: 4 products (113,717 units; 113,717 units; 113,717 units; 113717)
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.