Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98540

FDA · FDA event 98540 · Posted Apr 2, 2026

Published Apr 2, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Philips Respironics Trilogy Evo by Philips Respironics, Inc..

Products affected by FDA event 98540
Model	Description	Lot / serial range	Manufactured	Status
Z-1649-2026	Z-1649-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1646-2026	Z-1646-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1647-2026	Z-1647-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1648-2026	Z-1648-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing

Distribution: 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.
Units affected: See official FDA record
Category: Ventilators

Timeline

Mar 2, 2026
Recall initiated
Date recorded by the FDA.
Apr 2, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98540
Published: Apr 2, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Philips Respironics Trilogy Evo recall — FDA event 98540

FDA · FDA event 98540 · Posted Apr 2, 2026

Published Apr 2, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Philips Respironics Trilogy Evo by Philips Respironics, Inc..

Products affected by FDA event 98540
Model	Description	Lot / serial range	Manufactured	Status
Z-1649-2026	Z-1649-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1646-2026	Z-1646-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1647-2026	Z-1647-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing
Z-1648-2026	Z-1648-2026	All Model No.; All UDI; All Serial No.	Not provided in the normalized record	Ongoing

Distribution

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.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Philips Respironics Trilogy Evo recall — FDA event 98540

Follow Philips Respironics Trilogy Evo

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Philips Respironics Trilogy Evo recall — FDA event 98540

Follow Philips Respironics Trilogy Evo

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline