Official recall notice
FDA DeviceClass INotable
FDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
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.
Recommended action
What to do
113,717 units
Product description
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.