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

Recall date

December 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0915-2020

FDA classification

Class I

Brand / firm

ResMed Ltd.

Sold / distributed

U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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