FDA DeviceClass INotable

FDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Date: 2026-04-08
Brand: Philips Respironics, Inc.
Category: Medical Device
FDA Class: Class I

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.

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.

Remedy

113,717 units

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