HIGH

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Quick Facts at a Glance

Recall Date
March 2, 2026
Hazard Level
HIGH
Brand
Philips Respironics
Geographic Scope
1 states

Hazard Information

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Respironics, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.. Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.. Classification: Class I. Quantity: 113,717 units. Distribution: 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.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
All Model No.
All UDI
All Serial No.
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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