| TGA Action ID |
RC-2026-RN-00219-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mobile x-ray System
Model: MXU-RV35
Serial Numbers: 335, 362, 396, 394, 392, 398, 414, 457 |
| ARTG Number |
374584 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Micro-X has received customer complaints reporting a generator error that renders the product inoperable. Investigation identified the root cause as a PCBA component operating at its upper design threshold, which can lead to premature deterioration.
To date, no injuries have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Contact their local service representative to arrange replacement of the PCBA.
- Continue using the device in the interim. |
| Action Commencement Date |
24/03/2026 |
| Responsible Entity |
|
| Contact Information |
08 7099 3966 - Micro-X LTD |