Tag: field safety notice
Resmed discontinues Astral ventilator portfolio
October 19, 2026HME News Staff
SAN DIEGO – Resmed discontinued new sales of its Astral ventilator portfolio effective Sept. 14, 2026, according to a letter to customers.
The company says the decision allows it to prioritize available components and resources toward existing patients and continuity of care, following a field safety corrective action (FSCA).
“Ongoing supply constraints affecting critical electronic components have created significant challenges for the continued manufacture of Astral ventilators,”...
Vent manufacturers reassure providers
July 24, 2026Liz Beaulieu, Editor
YARMOUTH, Maine – Manufacturers are fielding calls from providers seeking guidance after Resmed issued a field safety notice for certain Astral ventilators and federal officials announced the end of COVID-era emergency use authorizations.
Resmed on July 15 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 supercapacitors leaking over time. The leakage, the company says,...
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 issues urgent field safety notice
November 21, 2023HME News Staff
SAN DIEGO – ResMed issued an urgent field safety notice to patients on Nov. 20, detailing a potential issue with its masks with magnets interacting with some implants or medical devices.
When a magnet comes close to certain medical implants/devices (less than 6 inches), the company says there is potential for magnetic interference to change:
the function of an implant/medical device
the position of implants made of ferromagnetic material
In...