ResMed Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0915-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Product Classification:
Class I
Date Initiated: December 12, 2019
Date Posted: February 12, 2020
Recall Number: Z-0915-2020
Event ID: 84551
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.
Status: Completed
Product Quantity: 69
Code Information:
Serial Number Range: 20160123307 to 22171057208
Distribution Pattern:
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Voluntary or Mandated:
Voluntary: Firm initiated