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Open, Classified

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

FDA Recall Z-1649-2026 · Posted 2026-04-02

Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2026-03-02
Product Quantity113,717 units

Reason for Recall

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Firm Action

An IMPORTANT PRODUCT NOTICE was mailed to consignees 6/5/24 about obstruction alarm compliance failure in Trilogy Evo devices. Refer to the most current version of the IFU in the event of an obstruction. A software update to correct this issue is pending. An UPDATED: URGENT FIELD SAFETY NOTICE was mailed 3/2/26 with recall information for three failure modes possible in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. This can lead to under-delivery of therapy to the patient. Update all devices with software version 1.05.15.00 through the My Philips for Professionals and InCenter websites. Stop use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors give your customers the provided recall notice and response form. DME and Homecare Customers call 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers call 1-800-722-9377 (option 2) for assistance. **An UPDATED: URGENT FIELD SAFETY NOTICE was mailed to consignees 4/24/26 with recall information for three failure modes possible in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. It clarifies and revises guidance about the use of non-pneumatic nebulizers with Trilogy Evo Platform ventilators communicated in the 3/2/26 update. This does not change this previously communicated information: Nebulized aerosol deposition on the internal flow sensor (FSN 2024-CC-SRC-013 - Flow Sensor Nebulized Aerosol Deposition), and Obstruction Alarm timing (IPN 2024-CC-SRC-002 - Obstruction Alarm). Consignees review the latest version of the User Manual Addendum, give the safety notice to all who interact with affected devices, and forward the notice to those to whom product was further distributed.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181170Trilogy Evo UniversalRespironics, Inc. · 2019-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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