ResMed Astral ventilators recalled for power loss and failed alarms
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a life-support device with a defect that can cause sudden loss of ventilation and failure of the backup alarm system. Although no deaths or injuries are currently reported, the potential for silent loss of respiratory support presents a serious risk.
Plain-English summary
ResMed has recalled 55,279 Astral 100 and Astral 150 ventilators manufactured between 2013 and 2019. The devices are distributed worldwide.
The recalled ventilators have a fault in the battery system that can cause sudden power loss while operating on internal battery. Although these devices are not intended to serve as a primary power source, and low/critically low battery alarms function normally, a defect may cause abrupt loss of power despite these warnings. When power fails, ventilation stops immediately. A Total Power Failure (TPF) alarm is designed to alert users to this power loss, but it relies on a supercapacitor that degrades over time. This degradation may cause the TPF alarm to sound for less than two minutes or not to sound at all, potentially leaving users unaware of the loss of ventilation.
Affected patients and healthcare providers should be aware of this hazard when using these ventilators.
The recalled product
- Product
- Astral 100 and Astral 150 ventilators
- Manufacturer
- ResMed Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- which includes the year of manufacture. For example
- if the serial number is 22151234567
- the 3rd and 4th digit are 15
- meaning the device was manufactured in 2015. Astral 100
- UDI: 00619498003259 Astral 150
- UDI: 00619498003266
Distribution
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