Public recall detail

Trilogy EVO and EV300

2026-02-13

medium
Anaesthesiology Device compatibility
Quick summary

Quick summary: Trilogy EVO and EV300. Reason: Device compatibility. Category: Anaesthesiology. Date: 2026-02-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Trilogy EVO and EV300. Reason: Device compatibility. Category: Anaesthesiology. Date: 2026-02-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRespironics Inc. Also Trading As Philips Rs North America Llc
ProductTrilogy EVO and EV300
IssueMedical devices - Device compatibility
Recall classType I
IdentificationRA-81599

Affected products

ProductTrilogy EVO
LotNot applicable.
ModelCA2110X12B
Serial numberNot applicable.
DescriptionTrilogy EVO
ProductTrilogy EV300
LotNot applicable.
ModelCA2200X12B
Serial numberNot applicable.
DescriptionTrilogy EV300

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, andthe 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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC 1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Recall date2026-02-10
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-81599
Background{}
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC 1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
AudiencesHealthcare Industry
Source updated2026-02-18

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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