| TGA Action ID |
RC-2025-RN-01043-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mazor X Robotic Guidance System
Model TPL0059
Software Version 5.0.1 or 5.1.2 or 5.1.3 |
| ARTG Number |
301912, 489553 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medtronic has identified anomalies concerning the software for the Mazor X robotic guidance system model TPL0059. The updated software version 5.2 contains incremental software improvements and corrections for refinements identified during internal testing and post-market surveillance. The majority of updates are associated with negligible patient severity impact. Seven problems will be corrected to further enhance system reliability and patient safety.
In rare circumstances and/or atypical workflows the problems may result in temporary workflow interruptions, extended procedure duration, the inability to proceed with robotic guidance or inaccuracy of the system with the potential for neurological injury.
No patient injuries or adverse clinical outcomes have been associated with the problems corrected with software version 5.2. |
| Instructions for Customers/Users |
Customers are to:
- Continue to use the Mazor X system as instructed in the user manual and with the mitigations provided in the customer letter.
Medtronic field service engineers will be in contact to schedule the software update of all Mazor X systems when available.
This action has been finalised on 27/10/2026. |
| Action Commencement Date |
16/12/2025 |
| Responsible Entity |
|
| Contact Information |
0434 815 851 - Abel Anzald, Medtronic Australasia |