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ResMed Ltd. recalls Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Recalled June 17, 2015 · FDA recall Z-1750-2015 · ResMed
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. · FDA Class II
Units
1519 units
Sold at
Worldwide distribution. US nationwide, Uruguay and Canada.
Description
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.
Product
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Manufacturer(s)
ResMed Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →