High risk Medical DevicesClass I

Philips Respironics Trilogy EV300 Ventilator Recall

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Updated March 2, 2026

Philips Respironics is recalling the Trilogy EV300 home ventilator running software version 1.05.15.00. When a non-pneumatic nebulizer is used with this device, the amount of air the patient actually receives may differ from the amount the ventilator is set to deliver, a potentially life-threatening discrepancy for people who depend on the machine to breathe.

Is the Philips Respironics, Inc. recalled? Yes. This product was recalled by FDA on March 2, 2026. Details below.

What is recalled

Philips Respironics Trilogy EV300 continuous home-use ventilator, software version 1.05.15.00.

Am I affected

You're affected if you use a Philips Respironics Trilogy EV300 ventilator and its software version is 1.05.15.00, check the device display or documentation for the software version number. The risk applies specifically when a non-pneumatic nebulizer is connected to the device.

What to do right now

Stop using non-pneumatic nebulizers with your Trilogy EV300 ventilator until further guidance is provided. Contact Philips Respironics directly, or have a caregiver or healthcare provider do so, for instructions on next steps. Do not stop using the ventilator itself without first consulting your doctor, as it may be life-sustaining equipment. Visit the FDA recalls page for updates: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

The hazard

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.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1616-2026
Classification
Class I
Recalled
March 2, 2026
Read the official notice

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