Z-1617-2026Class I

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

Name: Z-1617-2026 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

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 "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1617-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-02
Posted: 2026-03-26
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: 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.
FDA root cause: Under Investigation by firm
Action: An UPDATED: "URGENT FIELD SAFETY NOTICE" dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that 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. Consignees are being instructed to update all devices with software version 1.05.15.00 through the My Philips for Professionals and In Center websites. The provided Appendix B contains the required instructions. Consignees are also instructed to review the latest version of the User Manual Addendum, communicate the safety notice to all in their organization who interact with affect devices, and forward the notice to those who received product that was further distributed. Consignees are to stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors should notify their customers of this recall with the provided notice and response form. DME and Homecare Customers can contact 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers can contact 1-800-722-9377 (option 2) for assistance.
Quantity in commerce: 113717
Distribution: Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: 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, R¿union, 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-1617-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1615-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1616-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1617-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26

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)