FDA-Device2020-02-12Class I
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
ResMed Ltd.
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.
Sold states
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Affected count
69
Manufactured in
1 Elizabeth Macarthur Dr, N/A, Bella Vista, N/A, Australia
Products
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0915-2020Don't want to check this manually?
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