| TGA Action ID |
RC-2025-RN-00675-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Breas VIVO 45LS, 45 1,2, 3
Serviced or supplied between October 2023 and June 2025. |
| ARTG Number |
332260 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Discrepancy in the flow values of the Ventilator analyser have been identified, potentially leading to an incorrect flow rate. At low flows <100l/min this value is quite low (<5%), however it is more pronounced at higher flows.
There have been no reports of incident, harm or injury as a result of this discrepancy.
This market action does not affect any other devices supplied or serviced after June 2025 of VIVO 45LS, 45 1,2 3 or any other Taleb Medical products. |
| Instructions for Customers/Users |
Affected devices will be recalibrated as needed by Taleb Medical.
If the devices cannot be serviced on site, customers can organise to have the devices sent to the Taleb Medical workshop and will be provided a loaner device to avoid interruptions in care. |
| Action Commencement Date |
12/08/2025 |
| Responsible Entity |
|
| Contact Information |
03 9330 4940 - Tabel Medical |