Health product recall

Trilogy EVO and EV300

Last updated

Summary

Product
Trilogy EVO and EV300
Issue
Medical devices - Device compatibility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Trilogy EVO Not applicable. CA2110X12B
Trilogy EV300 Not applicable. CA2200X12B

Issue

Philips Respironics prohibits the use of non-pneumatic (e.g., vibrating mesh) nebulizers (FSN 2025-CC-SRC-020) with Trilogy EVO platform ventilators (including Trilogy EVO, Trilogy EVO O2, and Trilogy EV300 ventilators). The firm notifies clients about revisions to a prior field safety notice concerning nebulized aerosol deposition on the internal flow sensor (FSN 2024-CC-SRC-013 - flow sensor nebulized aerosol deposition)
Philips Respironics is no longer permitting the use of non-pneumatic nebulizers with Trilogy EVO platform ventilators.
These updates are necessary for ongoing safe and compliant functioning.

Philips Respironics has issued a follow-up letter to Field Safety Notice (FSN) 2026‑CC‑SRC‑002, to provide updated guidance regarding nebulizer use with the Trilogy Evo Platform ventilators (Trilogy Evo, Trilogy Evo O₂, Trilogy EV300).

*Updated Guidance:

Non‑pneumatic nebulizers may continue to be used, provided that:

  • they are positioned according to the updated nebulizer placement instructions, and
  • the warnings in the revised FSN are fully understood and followed.

This update clarifies that non‑pneumatic nebulizers (e.g., vibrating mesh) may continue to be used with Trilogy Evo ventilators, if they are positioned correctly according to the updated placement instructions. This revised guidance supports continuity of care in situations where other nebulization options are limited.

Philips Respironics will update the User Manual to include the new guidance on using non‑pneumatic nebulizers. A software update will also be released so the device interface clearly reflects that the guidance applies to both pneumatic and non‑pneumatic nebulizers. These updates will be included in a future release to limit repeated changes for users.

NOTE: This update does not change the previously communicated information regarding:

• Nebulized aerosol deposition on the internal flow sensor (FSN 2024-CC-SRC-013 – Flow Sensor Nebulized Aerosol Deposition)

For further support, contact your local Philips representative.

Related recalls and alerts

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Respironics Inc. Also Trading As Philips Rs North America LLC

1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type I
Recall date
Identification number
RA-81599

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