FDA Device recall Z-0111-2024
Astral 100 and Astral 150 ventilators
- FDA Device
- Class I
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class I recall of Astral 100 and Astral 150 ventilators by Resmed, citing 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 pow….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0111-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-13 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Resmed |
| Distribution | US |
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
Identifiers
| code_info | All devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufa…All devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufacture. For example, if the serial number is 22151234567, the 3rd and 4th digit are 15, meaning the device was manufactured in 2015. Astral 100, UDI: 00619498003259 Astral 150, UDI: 00619498003266 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0111-2024%22
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