Reported Feb 12, 2020 · Completed

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

ResMed Ltd.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ResMed Ltd. · 1 Elizabeth Macarthur Dr · Bella Vista, N/A · N/A

Is this the product you have?

  • ResMed Stellar, Non-invasive/invasive ventilators
  • Model
    • 100
    • 150
Lot codes and dates
  • Serial Number Range20160123307 to 22171057208
Amount recalled
69

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:21 PM UTC

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