Official recall notice
FDA Recall: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or int
- Recall date
- 2026-08-05
- Brand
- ResMed Ltd.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
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.
Product 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.
Affected products
Catalog Number: Astral 100 UDI-DI code: 00619498003259 Serial Numbers: Astral Ventilators-Serial number < 22241890149 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070 Catalog Number: Astral 150 UDI-DI code: 00619498270033 Serial Numbers: Astral Ventilator-Serial numbers < 22241440282 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070