Recall Z-2735-2026
- Recall number
- Z-2735-2026
- Event number
- 99304
- Firm
- ResMed Ltd.
- Firm FEI
- 3004604967
- Product code
- CBK
- Status
- Open, Classified
- Initiated
- 2026-06-25
- Posted
- 2026-07-28
- Root cause
- Component design/selection
- 510(k) numbers
- K152068, K172875, K822456, K844350, K912619, K840119, K252663, K781160, K960861, K871792, K241520, K911336, K113051, K922705, K010317, K073069, K980642, K102775, K900314, K821930, K110083, K111610, K895541, K823861, K923444, K183364, K100753, K063806, K861707, K864105
Product#
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Reason for Recall#
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.