FDAClass IFebruary 12, 2020

ResMed Stellar recall: Software Issue

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

Why was ResMed Stellar 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number Range: 20160123307 to 22171057208

Product
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Recalling firm
ResMed Ltd.
Quantity
69
Distribution
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Recall date
February 12, 2020
Classification
Class I
Status
Completed
Agency
FDA (device)
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