Reported Jun 17, 2015 · Terminated
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
ResMed Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Drive · Bella Vista, NSW, N/A · N/A
Is this the product you have?
- Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
- Lot codes and dates
- Serial No.
1,584 of 1,584 codes
221412567462214125674722141256749221412567502214125675222141256753221412567542214125675522141256756221412567572214125675822141256759221412567602214125676122141256762221412567632214125676422141256765221412567662214125676722141256768221412567702214125677122141256773221412567742214125677622141256777221412567782214125678022141256781221412567822214125678322141256784221412567852214125678622141256787221412567882214125678922141256790221412567922214125679322141256795221412567962214125679722141256798221412568002214125680222141256803221412568042214125680522141256808221412568092214125681022141256811221412568122214125681322141269796221412697972214126979822141269800
- Serial No.
- Amount recalled
- 1519 units
Where it was sold
- Nationwide
Why it was recalled
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.
This product could cause temporary or reversible health problems — stop using it.
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