Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0111-2024 — Astral 100 and Astral 150 ventilators

U.S. FDA — Device Enforcement · Australia · 2023-09-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0111-2024
Date of alert
2023-09-13
Country / jurisdiction
Australia
Risk level
Class I
Risk type
recall
Brand
ResMed Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
22151234567
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.