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

Recall date

March 2, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1614-2026

FDA classification

Class I

Brand / firm

Philips Respironics, Inc.

Sold / distributed

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,…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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