Recall Z-0111-2024— ResMed Ltd.

Name: FDA recall Z-0111-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-13

Class I · Ongoing

Class I FDA medical device recall by ResMed Ltd., initiated 2023-09-13. It names one FDA 510(k) clearance: K172875. Product: Astral 100 and Astral 150 ventilators. Reason: 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.

Recalling firm: ResMed Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2023-09-13
Firm location: Bella Vista, N/A, Australia

510(k) clearances named in this recall

1 on FDA's record

K172875 — Astral 100/150Resmed, Ltd.·cleared 2018-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Astral 100 and Astral 150 ventilators

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.