FDA-Device2026-04-08Class IPROCESSING DEFECT
Philips Respironics Trilogy EV300 ventilator recalled for delayed obstruction alarm
What this means
Philips Respironics has recalled certain Trilogy EV300 home ventilators (software version 1.05.15.00) because the obstruction alarm may not trigger quickly enough if the breathing tube becomes blocked. In rare cases, the alarm could be delayed by up to four breaths, which is longer than safety standards allow.
- Contact Philips Respironics or your equipment supplier immediately if you use this device
- Do not stop using your ventilator unless instructed by your doctor
- Ask your supplier about a software update or replacement device
- Report any alarm problems or breathing difficulties to your physician right away
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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 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-1648-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.