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MEDICAL DEVICE RECALLCRITICAL

Philips Respironics Trilogy Evo O2 Ventilator

Philips Respironics recalls Trilogy Evo O2 ventilators (SW 1.05.15.00) over delayed obstruction alarm.

What to do

If you use a Philips Respironics Trilogy Evo O2 ventilator with software version 1.05.15.00, contact Philips Respironics immediately to arrange for a software update. Do not stop using the ventilator without consulting your healthcare provider, as the device is critical for breathing support. Monitor the device closely and seek immediate medical attention if an obstruction is suspected.

Recalled
Listed
Updated
Recall No.
Z-1649-2026
Agency
FDA
Firm
Philips Respironics, Inc.
Recall ID
98540
Status
ONGOING

Recall at a glance

Quantity recalled
113,717 units

Why it was recalled

Philips Respironics is recalling the Trilogy Evo O2 continuous home-use ventilator with software version 1.05.15.00 because the Obstruction Alarm may not trigger within the required timeframe, potentially taking up to four breaths. This could delay alerting caregivers to a blocked airway, posing a serious risk to patients.

Is mine affected?

This recall covers the products below. If you have any of them, yours is affected.

Philips Respironics Trilogy

ProductRecall #
EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1648-2026
Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1649-2026
Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1647-2026
Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1646-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Philips Respironics, Inc.

All recalls from Philips Respironics, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification