Tag: Astral 100
FDA updates early alert for Resmed vents
August 5, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has updated its early alert for certain Resmed Astral ventilators to a recall. “The affected products and recommendations for what to do with the devices have not changed,” the agency stated. “This recall involves correcting certain devices and does not involve removing them from where they are used or sold.” The FDA has identified the recall as the most serious type, with the potential to cause serious injury...
UPDATED: FDA issues early alert of potential issue with Resmed Astral
July 16, 2026HME News Staff
WASHINGTON - The U.S. Food and Drug Administration (FDA) on July 15 issued an early alert to notify the public of a potentially high-risk device issue with certain Resmed Astral 100 and Astral 150 ventilators.
The FDA said it is aware that Resmed has issued a voluntary Global Medical Device Correction / Field Safety Notice for its Astral 100 and Astral 150 ventilators built prior to October 2024 due to the potential of a component called a supercapacitor leaking over time. The leakage...
Resmed issues correction for certain Astral vents
July 15, 2026HME News Staff
SAN DIEGO – Resmed has issued a voluntary global Medical Device Correction / Field Safety Notice for its Astral 100 and Astral 150 ventilators built prior to October 2024. At issue: The vents may stop delivering therapy due to an internal component issue.
The company says that in a subset of Astral 100 and Astral 150 vents a component called a supercapacitor may leak over time, potentially causing damage to internal parts and resulting in the vents incorrectly entering a protective...
ResMed recalls vents in Australia
September 1, 2016HME News Staff
SAN DIEGO - ResMed, in consultation with the Australian Government Department of Health Therapeutic Goods Administration, has initiated a product correction recall in that country for its Astral 100 and Astral 150 ventilators due to an internal battery issue. Starting in September, local service providers will be contacting patients to schedule replacement of affected batteries, either at the next normal routine maintenance service or at a separate appointment. All ventilators should have their internal...