FDA DevicesClass I
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home...
Published: April 8, 2026Recall ID: Z-1647-2026Category: devicesCountry: US
Reason for Recall / Hazard
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Product Description & Identification
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Additional Source Details
| Field | Value |
|---|---|
| City | Murrysville |
| State | PA |
| Event id | 98540 |
| Address 1 | 1001 Murry Ridge Ln |
| Code info | All Model No.; All UDI; All Serial No. |
| Postal code | 15668-8517 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 113,717 units |
| Reason for recall | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260302 |
| Initial firm notification | Letter |
| Center classification date | 20260402 |
Overview
- Recalling FirmPhilips Respironics, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide Distribution. US Nationwide, 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, Reunion, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.