| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00877-1 |
| Product Name/Description |
Micro-X Rover
Model number: MXU-RV35, MXU-RV71
ARTG 374584
(Micro-X Ltd - X-ray system, diagnostic, general-purpose, mobile, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
On 28 November 2023, a customer letter was issued to customers to announce replacements of control boards PCBA. During Rover (MXU-RV35) compliance testing at the customer’s site, it was found that at 70kv 80mAs, the Rover can report and deliver a lower post-exposure mAs value than what is set by the operator.
This recall action was not notified to the TGA prior to being undertaken. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers have been advised to replace the control board via the following instructions:
1. Power down Micro-X Rover and ensure generator capacitors are depleted
2. Obtain access to the Rover generator control board per the service manual
3. Control boards requiring replacement are P12425 R03 and earlier. R03 boards with rework D annotated do not require replacement.
4. Replace the control board with the revised board and reassemble the Rover unit.
5. Power on Rover unit and conduct compliance testing on the unit. |
| Contact Information |
support@micro-x.com - Micro-X Customer Support |