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-1646-2026
- FDA classification
- Class I
- Brand / firm
- Philips Respironics, Inc.
- Sold / distributed
- 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, Fr…
Why it was recalled
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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.
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