Philips Respironics, Inc.

Device Recalls (Class I)

← All Device Recalls (Class I)
Class I Z-1616-2026 · 20260401 · Ongoing

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, Belgi...