Z-1649-2026Class I

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

Name: Z-1649-2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device
Creator: Philips Respironics, Inc.
Published: 2026-03-02
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2026-03-02 / Open, Classified / root cause: software

FDA source

Philips Respironics, Inc. began a recall of Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device on 2026-03-02. FDA classified it as Class I and gives the reason as "In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1649-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-02
Posted: 2026-04-02
Recalling firm: Respironics, Inc.
Product: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 113,717 units
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.
Product codes and lots: All Model No.; All UDI; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1649-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1646-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1647-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1648-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1649-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

Product code CBK

K181170Class IITrilogy Evo UniversalRespironics, Inc. / cleared 2019-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)