| TGA Action ID |
RC-2025-RN-00379-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Micro-X Rover Mobile X-Ray System
Model: MXU-RV35
Serial Numbers: #335, #363
The Serial Numbers affected have been distributed since November 2023 |
| ARTG Number |
374584 |
| Unique Device Identifier (UDI) |
Please refer to product traceability list attached. |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Micro-X has received several product complaints from customers in the United States regarding failures in the internal fastening mechanism of the generator. These failures have led to the partial separation of the capacitor bank (an integral part of the generator) from the main assembly, rendering the device mechanically inoperable.
Potential risk to the patient is delay in diagnosis and treatment.
There is no increased risk for the operator. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine affected stock on hand to prevent further use until a suitable correction is implemented by a Micro-X service agent.
- Contact their nominated Service representative to arrange product correction or Email: support@micro-x.com.
Product correction consists of installing generator capacitor bank support brace to provide suitable generator support.
This action has been closed out on 09/07/2025 |
| Action Commencement Date |
8/04/2025 |
| Responsible Entity |
|
| Contact Information |
08 7099 3966 or admin@micro-x.com - Micro-X |