FDA-Device2026-04-01Class IPROCESSING DEFECT
Philips Respironics Trilogy Evo O2 ventilator recalled for inaccurate breath delivery with certain nebulizers
OTHERNationwide distribution
Check your Philips Respironics ventilator settings
Philips Respironics has recalled certain Trilogy Evo O2 home ventilators because using non-pneumatic nebulizers with them may cause a mismatch between the breath volume set on the machine and the volume actually delivered to the patient. This discrepancy could result in the patient receiving too much or too little air during ventilation.
- Contact Philips Respironics immediately if you use a Trilogy Evo O2 ventilator with a non-pneumatic nebulizer
- Do not use non-pneumatic nebulizers with your Trilogy Evo O2 until you receive guidance from Philips
- Ask your doctor or respiratory therapist which nebulizers are safe to use with your ventilator
- Check for software updates or instructions from Philips Respironics
Hazard
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.
Sold states
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.
Affected count
113,717 units
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2026More 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-Device2026-04-08Philips Respironics Trilogy Evo ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-01Philips Respironics Trilogy Evo ventilator recalled for inaccurate breath volume delivery with certain nebulizers
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