ResMed Ltd.: Astral 100 and Astral 150 Ventilators Recalled for Sudden Power Loss

Agency Publication Date: October 23, 2023

Summary

ResMed Ltd. is recalling approximately 55,279 Astral 100 and Astral 150 ventilators because they can experience an unexpected loss of power while running on internal battery. A mechanical fault leads to sudden power loss, and a backup alarm meant to warn caregivers may sound for less than two minutes or not at all because an internal component degrades over time. These ventilators, manufactured between 2013 and 2019, are used to provide breathing support for patients, and a failure could lead to the immediate cessation of ventilation.

Risk

If the ventilator loses power suddenly and the backup alarm fails to alert caregivers, the patient will stop receiving breathing support without warning. This poses a critical risk of serious injury or death for patients who cannot breathe on their own.

What You Should Do

Check the label on your Astral 100 or Astral 150 ventilator to locate the serial number.
Verify the year of manufacture by looking at the 3rd and 4th digits of the serial number; devices manufactured between 2013 and 2019 (indicated by digits 13, 14, 15, 16, 17, 18, or 19) are affected.
Confirm if your device matches UDI 00619498003259 for the Astral 100 or UDI 00619498003266 for the Astral 150.
Ensure the ventilator is connected to a stable external power source at all times, as the internal battery is not intended to be used as the primary power source.
Contact your healthcare provider or ResMed Ltd. immediately for further instructions on how to manage your device and to discuss potential repair or replacement options.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

Other Action

Manufacturer instructions regarding power failure risks and device monitoring.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Astral 100 ventilator

Model / REF:

Astral 100

UPC Codes:

00619498003259

Date Ranges: 2013 - 2019

Product: Astral 150 ventilator

Model / REF:

Astral 150

UPC Codes:

00619498003266

Date Ranges: 2013 - 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93122

Status: Active

Manufacturer: ResMed Ltd.

Sold By: medical equipment suppliers; healthcare providers

Manufactured In: Australia

Units Affected: 55,279 (US 16,634; OUS 38,645)

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check the label on your Astral 100 or Astral 150 ventilator to locate the serial number.

Verify the year of manufacture by looking at the 3rd and 4th digits of the serial number; devices manufactured between 2013 and 2019 (indicated by digits 13, 14, 15, 16, 17, 18, or 19) are affected.

Confirm if your device matches UDI 00619498003259 for the Astral 100 or UDI 00619498003266 for the Astral 150.

Ensure the ventilator is connected to a stable external power source at all times, as the internal battery is not intended to be used as the primary power source.

Contact your healthcare provider or ResMed Ltd. immediately for further instructions on how to manage your device and to discuss potential repair or replacement options.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.