medical HIGH RISK Updated 2020-02-12

ResMed Ltd. recalls ResMed Stellar, Non-invasive/invasive ventilators, Model: 10

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: PA, MA, VA, TN, CT, IL, GA, FL, MT
Lot/Code Info: Serial Number Range: 20160123307 to 22171057208

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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