FDADecember 12, 2019device
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
What to do
FDA enforcement status: Completed
Brands named
resmed
UPCs
2016012330722171057208
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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