| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00338-1 |
| Product Name/Description |
AirSense 11 devices
Multiple Products and Product Codes
ARTG 222485
(Resmed Limited - Home CPAP unit) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Resmed is providing a software update to help reduce the occurrence of humidification error messages displayed on AirSense 11 devices and triggered under certain operating conditions.
The device systems respond as designed and turn off power to the heated humidification for the rest of the active therapy session.
The user is notified with a humidification error message on the device.
AirSense 11 devices displaying the humidifier error message are safe to use and there is no disruption to therapy.
The heated humidification setting is a feature that provides comfort during therapy.
To restart heated humidification, the user needs to acknowledge the error message, stop, and then restart therapy. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Actions to be taken by the AirSense 11 user:
-To receive the OTA software update, the AirSense 11 device must be connected to a power source and cellular network.
-The OTA update will occur automatically once the user has ended their therapy session and the device is on the Home Screen.
No additional action is needed to initiate or accept the OTA update.
-Once the AirSense 11 device receives the OTA update, it will take approximately 30 seconds to complete.
-If the device is not connected to the cellular network when the OTA update is deployed, the update will be processed the next time the device connects to the cellular network.
Note: airplane mode must be turned off.
Resmed is advising that starting from the 16th of May 2024, they will start rolling out the software update. |
| Contact Information |
(02) 8884 1000 - ResMed Pty Ltd |