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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Number Range: 20160123307 to 22171057208
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ResMed Ltd.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Serial Number Range: 20160123307 to 22171057208

Distribution:

Distributed in: PA, MA, VA, TN, CT, IL, GA, FL, MT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0915-2020

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