Reported Nov 1, 2023 · Ongoing
Astral 100 and Astral 150 ventilators
ResMed Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ResMed Ltd. · 1 Elizabeth Macarthur Dr · Bella Vista, N/A · N/A
Is this the product you have?
- Astral 100 and Astral 150 ventilators
- Lot codes and dates
- All devices manufactured between 2013 and 2019. Device label lists the serial number, 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
- UDI00619498003259 Astral 150
- UDI00619498003266
- Amount recalled
- 55,279 (US 16,634; OUS 38,645)
Where it was sold
Why it was recalled
Stop using this product now
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all
Using this product could cause serious injury, illness or death — stop using it now.
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