FDA-Device2026-04-08Class IPROCESSING DEFECT
Philips Respironics Trilogy Evo ventilator recalled for delayed obstruction alarm
OTHERNationwide distribution
Check your Philips Respironics Trilogy Evo ventilator
Some Philips Respironics Trilogy Evo home ventilators with Software Version 1.05.15.00 may not sound their obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time a user has to respond to an airway obstruction.
- Contact Philips Respironics to check if your device is affected and to discuss next steps
- Do not stop using your ventilator without talking to your doctor first
- Keep emergency contact information for your respiratory care provider readily available
Hazard
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Sold states
Domestic: Nationwide Distribution; Foreign: 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.
Affected count
113,717 units
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2026More Philips Respironics, Inc. recalls
- FDA-Device2026-04-08Philips Respironics Trilogy Evo O2 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo Universal ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy EV300 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-01Philips Respironics Trilogy Evo ventilator recalled for inaccurate breath volume delivery with certain nebulizers
- FDA-Device2026-04-01Philips Respironics Trilogy EV300 ventilator recalled for inaccurate breath delivery with certain nebulizers
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