| TGA Action ID |
RC-2025-RN-00761-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Patient monitor Vista 120/Vista120s |
| ARTG Number |
294160, 314265 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Under certain conditions, the monitor can temporarily freeze without an alarm or restart being triggered.
Analyses have shown that such screen freeze may happen if e.g. the users deviate from the instructions for use. In particular, the freeze may occur if the Vista 120 detects a damaged or full storage device. If so, the monitor will display a corresponding prompt/ icon. |
| Instructions for Customers/Users |
Customers should read and affix the supplement, contained within the customer letter, to their instructions for use and inform both all staff engaged in the device of the supplement and of the necessity to comply with the amended instructions.
This action has been finalised on 19/12/2025. |
| Action Commencement Date |
4/09/2025 |
| Responsible Entity |
|
| Contact Information |
1800 372 437 - Customer service |