| TGA Action ID |
RC-2025-RN-00949-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Clearway 2 Mechanical Insufflation-Exsufflation
Devices manufactured between 01 November 2023 and 23 March 2025
Devices repaired between 01 November 2023 and 23 March 2025 (firmware version 3.0.0 or earlier.)
Serial numbers: 20234937 and 202511779 |
| ARTG Number |
311624 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
A limited number of devices may exhibit an unresponsive touchscreen after power-on, prior to starting treatment. The device cannot be operated while this condition prevails. The device may still be switched off using a long press of the power button.
This problem is linked to two causes:
1. A firmware defect in firmware versions 3.0.0 or earlier. The defect was already corrected in firmware version 3.1.0, released in January 2025.
2. A supplier defect in earlier revisions of touchscreens, used in Clearway 2 devices manufactured or serviced between 01 November 2023 and 23 March 2025.
This problem may result in the inability to start treatment or a delay in airway clearance therapy.
Globally, 9 incidence reports have been received related to this problem, with no reports of actual patient harm. |
| Instructions for Customers/Users |
Taleb Medical will update devices to the most recent firmware version when customers have their next annual service performed.
In the interim, devices not experiencing the touchscreen problem can continue to be used.
If an unresponsive touchscreen occurs, users should first attempt to power the device off, then on again. If this does not resolve the problem, users should contact the sponsor to arrange for the repair.
The risk for patient or user harm remains low since the function of the manual switch is independent of the touchscreen, and an ongoing session could be completed by using the manual switch. |
| Action Commencement Date |
14/11/2025 |
| Responsible Entity |
|
| Contact Information |
03 9330 4940 - Taleb Medical and Vetequip Australia |