| 2026-06-25 |
Class I
|
Ongoing |
Z-2735-2026 |
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilator… |
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Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ve… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0542-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0541-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0540-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0539-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0538-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0537-2024 |
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 interac… |
| 2023-11-20 |
Class I
|
Ongoing |
Z-0536-2024 |
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 interac… |
| 2023-09-13 |
Class I
|
Ongoing |
Z-0111-2024 |
Astral 100 and Astral 150 ventilators |
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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… |