FDA-Device2026-04-01Class IPROCESSING DEFECT
Philips Respironics Trilogy EV300 ventilator recalled for inaccurate breath delivery with certain nebulizers
OTHERNationwide distribution
Stop using Philips Respironics Trilogy EV300 with non-pneumatic nebulizers
Philips Respironics has recalled Trilogy EV300 ventilators (software version 1.05.15.00) because using them with certain types of nebulizers can cause the device to deliver a different amount of air to the patient than what was set. This mismatch between the intended and actual breath volume could affect patient safety.
- If you use a Trilogy EV300 ventilator at home, contact Philips Respironics or your equipment provider immediately
- Do not use non-pneumatic nebulizers with your Trilogy EV300 until you receive guidance from Philips
- Ask your provider which nebulizer types are safe to use with your ventilator
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 EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief