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

Company / brand

Philips Respironics, Inc.

Product

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

Reason / 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.

Classification

Class I

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-03-02

Code info

All Model No.; All UDI; All Serial No.

Product quantity

113,717 units

Voluntary mandated

Voluntary: Firm initiated

City

Murrysville

State

PA

Country

United States

Event id

98537

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