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MEDICAL DEVICE RECALLCRITICAL

Philips Respironics Trilogy Evo Ventilator

Philips Respironics recalls Trilogy Evo ventilators over tidal volume discrepancy with non-pneumatic nebulizers.

What to do

Check your ventilator's software version. If it is 1.05.15.00, contact Philips Respironics for instructions on corrective actions and to arrange for a software update or other remediation. Do not use non-pneumatic nebulizers with the device until the issue is resolved.

Recalled
Listed
Updated
Recall No.
Z-1617-2026
Agency
FDA
Firm
Philips Respironics, Inc.
Recall ID
98537
Status
ONGOING

Why it was recalled

Philips Respironics is recalling Trilogy Evo continuous home-use ventilators, software version 1.05.15.00, because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume received by the patient.

Is mine affected?

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

Philips Respironics Trilogy

ProductRecall #
Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1617-2026
EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1616-2026
Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1615-2026
Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Z-1614-2026

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