| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00512-1 |
| Product Name/Description |
Barco Surgical Displays
Surgical Display MDSC-2224 (24 inch) Part Numbers K9307912, K9307913, K9307916 and K9307917
Surgical Display MDSC-2226 (26 inch) Part Numbers K9307906, K9307907 and K9307908
Surgical Display MDSC-2242 (42 inch) Part Numbers K9307914 and K9307915 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
The surgical display types listed above could lose the user- defined settings, including failover, under the following condition:
After being in stand-by mode or being in autosearch mode for at least an accumulative time of 4,152 hours (173 calendar days) and the unit is powered off and back on, or went into stand-by mode and back on.
The accumulative time does not need to be continuous. One of the lost settings is the user setting for automatic failover switching.
Barco has investigated this behaviour and confirms that both the failover mode and user (defined) profile settings will indeed be lost on the products involved. However, the factory settings are never lost.
The behaviour is caused by a firmware issue on the Barco surgical displays listed below |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As a short term solution Barco is recommending that end users either:
- Verify the correctness of the failover mode setting in the user settings before each use; or
- Disable the failover mode in the user settings of the OSD and if needed switch manually to the backup source.
With this intermediate fix, the display can continue its normal operation, until the final corrective action will be implemented.
Barco is currently validating a new firmware version which will fix the issue. This action has been closed-out on 22/08/2016. |
| Contact Information |
03 9646 5833 - Barco Service Team |