High risk Medical DevicesClass I

Philips Respironics Trilogy Evo Universal Ventilator Recall

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

Updated March 2, 2026

Philips Respironics has recalled the Trilogy Evo Universal home ventilator running software version 1.05.15.00. When a non-pneumatic nebulizer is used with the device, the patient may receive a different amount of air than the ventilator is set to deliver, a potentially life-threatening breathing risk for people who depend on the machine.

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 Evo Universal continuous home-use ventilator, Software Version 1.05.15.00. Manufactured by Philips Respironics, Inc.

Am I affected

You're affected if you or someone in your care uses a Philips Respironics Trilogy Evo Universal ventilator running software version 1.05.15.00, and especially if a non-pneumatic nebulizer is used alongside it. Check the device's software version in its settings or on its label.

What to do right now

Stop using non-pneumatic nebulizers with this ventilator immediately. Because no consumer contact information was provided in this recall, contact Philips Respironics directly or ask your prescribing clinician or home health equipment provider for guidance on safe alternatives. Do not adjust ventilator settings on your own.

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-1617-2026
Classification
Class I
Recalled
March 2, 2026
Read the official notice

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