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Recall Observatory FDA recall evidence

Device product

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

Z-0915-2020

December 12, 2019

Class I

Product summary

Firm
ResMed Ltd.
Event
Event 84551
Status
Completed
Classification
Class I
Quantity
69
Official record key
device-enforcement:Z-0915-2020

Official wording

Reason: 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.

Code information: Serial Number Range: 20160123307 to 22171057208

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software and a component failure