FDA DeviceClass INotable

FDA Recall: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or int

Date: 2026-08-05
Brand: ResMed Ltd.
Category: Medical Device
FDA Class: Class I

Description

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

Hazard

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

Remedy

168,069 devices globally

Related Recalls