| TGA Action ID |
RC-2026-RN-00564-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mindray Monitors
Multiple Models |
| ARTG Number |
166368, 223384, 223385, 230637 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Mindray has identified that certain monitor manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.
To improve clarity and ensure consistency between the manual content and device performance, Mindray is issuing a manual addendum addressing the following items:
Revision A: Revised description of the “PVC” alarm
Revision B: Revised description of the “Pause” alarm
Revision C: Revised description of the “Pauses/min” alarm
Revision D: Added a note regarding the Pause with PVC-related arrhythmias alarm switch
Revision E: Updated description of the “Arrhythmia Refractory Periods” function
Manual revision items vary by monitor model. |
| Instructions for Customers/Users |
Customers can continue using the Mindray monitors associated with the affected operator’s manual. No device removal, return, repair, or replacement is required as part of this action.
Customers should refer to the manual addendum in the customer letter sent by Mindray for specific details of the device they use
Mindray Medical Australia service team and/or authorised distributors will send customers the electronic manual addendum. |
| Action Commencement Date |
31/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 793 011 - Mindray Medical Australia Service team |