| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00875-1 |
| Product Name/Description |
Rover mobile X-Ray Unit
Model number: RV-19
Serial numbers: All
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 |
Micro-X have released an upgrade for the installation of an exposure switch holder on the Rover mobile X-Ray Unit. The exposure switch holder attachment will reduce the probability of the exposure button being pressed inadvertently while stored and allow easier access to the exposure button when required.
There is no adverse event reported to date.
This action was undertaken prior to consultation with the TGA. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers were asked to:
1) Remove the storage back panel by referring to ROV364 Adjustments and replacements for the MX Rover mobile x-ray system.
2) Use the provided jig to align and mark where holes should be drilled. The top holes should be drilled at 55mm to align the starting position.
3)Attach the gasket to the lower side of the storage back panel.
4) Attach the holder to the casing.
5) Reinstall the storage back panel cover and to take caution while removing covers, ensuring that the system was off prior disassembly, and while creating holes using correct PPE and tooling. |
| Contact Information |
support@micro-x.com - Micro-X Customer Support |