FDA recall Z-1616-2026

Philips Respironics, Inc. · Class I · device

Product

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2026-03-02
Report date
2026-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2026