Health ProductsType I recall

Trilogy EVO and EV300

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Trilogy EVO and EV300
Issue: Medical devices - Device compatibility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Trilogy EVONot applicable.CA2110X12B
Trilogy EV300Not 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.

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