| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00870-1 |
| Product Name/Description |
EIZO Medical Monitors
Model Name: RX440, RX650, RX850 and GX540-CL
Affected Range:
RX440 - S/N 20001112 - 20931104
GX540 - S/N 20001013 - 25409114, S/N 20001283 - 20210324
RX650 - S/N 20001123 - 20766074
RX850 - S/N 20001024 - 20133074
ARTG Number: 115740 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal quality control audit has revealed that image degradation (below 10bit) may occur when monitors are connected by display port on certain graphics boards. When starting up a computer or returning from sleep mode, an affected monitor displays 6-bit (64 graduations) instead of normal 8-bit (256 graduations) or 10-bit (1024 graduations).
This may not be recognised by the medical images, although it can be recognised by the grey-scale images and may affected diagnostic images. Monitors connected by DVI are not affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Eizo is providing interim instructions for users to follow to identify if the users are affected by the issue. A firmware update will be provided as a permanent fix. This action has been closed-out on 18/08/2016. |
| Contact Information |
02 9462 7500 - EIZO |