FDAMay 5, 2015device
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
resmed
UPCs
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAirFit F20 Full Face Mask and User Guide2023-11-20
- FDAAirFit N10 Nasal Masks and User Guide2023-11-20
- FDAAirFit N20 Nasal Mask and User Guide2023-11-20
- FDAAirTouch N20 Nasal Mask and User Guide2023-11-20
- FDAAirFit F30 Full Face Mask and User Guide2023-11-20
- FDAAirFit F30i Full Face Mask and User Guide2023-11-20
- FDAAirTouch F20 Full Face Mask and User Guide2023-11-20
- FDAAstral 100 and Astral 150 ventilators2023-09-13
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