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

Class I
Recalling firm
Philips Respironics, Inc.
Reason for recall
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.
Affected products (lot / model / serial)
All Model No.; All UDI; All Serial No.
Units affected
113717
Distribution pattern
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.
Firm location
Murrysville, PA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-1617-2026
Recall initiated
March 2, 2026
FDA classification date
March 26, 2026
FDA report date
April 1, 2026
FDA event ID
98537
Last updated on HTM Vibe
July 24, 2026
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