| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00194-1 |
| Product Name/Description |
ResScan 7.0 on AirSense 11 AutoSet device
ARTG 374473
(Resmed Pty Ltd - Ventilator, software) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
A software bug has been identified in the ResScan 7.0 (2.6) software. Under certain conditions, the therapy mode and device settings could inadvertently be changed. This issue only affects AirSense11 devices.
If the following steps occur, the active therapy mode is changed from AutoSet to CPAP, with pre-existing CPAP therapy settings becoming active. This could be factory default CPAP settings or anything that the clinician has previously configured for the patient.
To inadvertently change the patient’s therapy mode and settings, the clinician would need to:
1. Remove the SD card from the device and access the data using ResScan 7.0 or later.
2. Access the Device Settings option in ResScan.
3. Unselect the Settings panel’s checkbox so that therapy settings are not applied.
4. Press the ‘Apply’ button.
5. Re-insert the SD card into the AirSense11 device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to download ResScan 7.1 software which corrects the issue.
Customers are to contact their ResMed account manager or email anzsales@resmed.com.au should they need any assistance. |
| Contact Information |
1300 305 705 - ResMed Pty Ltd |