FDA-Device2015-06-17Class II
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
ResMed Ltd.
Hazard
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.
Sold states
Worldwide distribution. US nationwide, Uruguay and Canada.
Affected count
1519 units
Manufactured in
1 Elizabeth MacArthur Drive, N/A, Bella Vista, NSW, N/A, Australia
Products
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1750-2015Don't want to check this manually?
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