ResMed Ltd. recalls Astral 100 and Astral 150 ventilators

Recall date

September 13, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0111-2024

FDA classification

Class I

Brand / firm

ResMed Ltd.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain…

Why it was recalled

If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Astral 100 and Astral 150 ventilators