ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Recall #Z-0915-2020 — Class I — December 12, 2019
Product Description
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Reason for Recall
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.
Recalling Firm
ResMed Ltd. — Bella Vista, N/A
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
69
Distribution
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Code Information
Serial Number Range: 20160123307 to 22171057208
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated