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ResMed Ltd. recalls ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Recalled February 12, 2020 · FDA recall Z-0915-2020 · ResMed
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. · FDA Class I
Units
69
Sold at
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Description
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.
Product
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Manufacturer(s)
ResMed Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →