ResMed Recalls

10 recalls on record in the United States

medical: 10
medical Class I
2023-12-27

ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

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medical Class I
2023-12-27

ResMed Ltd. recalls AirTouch N20 Nasal Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

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medical Class I
2023-12-27

ResMed Ltd. recalls AirFit F30 Full Face Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

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medical Class I
2023-12-27

ResMed Ltd. recalls AirFit N10 Nasal Masks and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

View recall details →

medical Class I
2023-12-27

ResMed Ltd. recalls AirFit F20 Full Face Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

View recall details →

medical Class I
2023-12-27

ResMed Ltd. recalls AirFit F30i Full Face Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

View recall details →

medical Class I
2023-12-27

ResMed Ltd. recalls AirFit N20 Nasal Mask and User Guide

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

View recall details →

medical Class I
2023-11-01

ResMed Ltd. recalls Astral 100 and Astral 150 ventilators

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

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medical Class I
2020-02-12

ResMed Ltd. recalls ResMed Stellar, Non-invasive/invasive ventilators, Model: 10

Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.

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medical Class I
2026-08-05

ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilato

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

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