medical Class I Updated 2020-02-12

ResMed Ltd. recalls ResMed Stellar, Non-invasive/invasive ventilators, Model: 10

Recalled Product

ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150


Hazard / Issue

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.

Issued by

FDA

Affected States: PA, MA, VA, TN, CT, IL, GA, FL, MT
Lot/Code Info: Serial Number Range: 20160123307 to 22171057208
View official government recall

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