FDA DevicesClass I
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-...
Published: April 1, 2026Recall ID: Z-1616-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Additional Source Details
| Field | Value |
|---|---|
| City | Murrysville |
| State | PA |
| Event id | 98537 |
| Address 1 | 1001 Murry Ridge Ln |
| Code info | All Model No.; All UDI; All Serial No. |
| Postal code | 15668-8517 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 113,717 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260302 |
| Initial firm notification | Letter |
| Center classification date | 20260326 |
Overview
- Recalling FirmPhilips Respironics, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide 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.