ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk
ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which under the rubric corresponds to a reasonable probability of serious adverse health consequences or death. Therefore the severity score is 5 (Critical).
Plain-English summary
ResMed is recalling its Astral 100 and Astral 150 ventilators, which provide continuous or intermittent ventilatory support for patients weighing more than 11 lb (5 kg) who require mechanical ventilation. The recall covers 168,069 devices globally, and the FDA has classified it as a Class I recall.
The recall was issued because supercapacitor electrolyte leakage on the printed circuit board assembly (PCBA) can damage the charger chip. This damage may cause the ventilator to enter a fail-safe state and interrupt ventilation therapy.
The affected devices were distributed nationwide in the United States and in many countries worldwide. The recall notice includes specific UDI-DI codes and serial-number ranges for identifying affected ventilators and spare parts.
Patients, caregivers, and providers should check the FDA recall notice to determine whether their device is affected and follow the instructions in the notice.
The recalled product
- 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.
- Manufacturer
- ResMed Ltd.
- Hazard
- electrolyte-leakage
- ventilation-interruption
- device-failure
Distribution
Distributed nationwide across the United States.
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