ResMed ventilators recall is Class I
FDA today designated a ResMed (NYSE:RMD) recall of certain Stellar non-invasive and invasive ventilators as Class I — the agency’s most serious level.
The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, or powers on automatically when connected to AC power without pressing the power switch, according to FDA.