FDA-Device2026-04-08Class IPROCESSING DEFECT
Philips Respironics Trilogy Evo Universal ventilator recalled for delayed obstruction alarm
What this means
Philips Respironics has recalled certain Trilogy Evo Universal home ventilators (Software Version 1.05.15.00) because the obstruction alarm may not trigger as quickly as safety standards require. In some cases, the alarm could be delayed by up to four breaths, which may prevent timely notification of a breathing tube blockage.
- Contact Philips Respironics immediately if you use this ventilator model to learn about a software update or next steps
- Do not stop using your ventilator—speak to your doctor or respiratory therapist about safety measures while waiting for instructions
- Check your device's software version (1.05.15.00) and serial number against Philips Respironics' recall list
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 Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1649-2026Want us to check the next one for you?
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