| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00851-1 |
| Product Name/Description |
Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
Part number: 1707.05A0
ARTG number: 185134 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
A Tegris system that has a second touch monitor used to operate the operating room (OR) table, is not equipped with an emergency stop button. In an unlikely event of malfunction of the table control module, which could lead to unexpected movement of the OR table, this secondary touch monitor could not be used to stop the table in an emergency situation. Thus, the intended immediate stop of the table movement could be delayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is providing instructions to the user to disconnect both the primary and secondary touch screens from the OR table. The table can still be controlled by the corded or infrared hand control. A second emergency stop button will be installed on all existing and future secondary touch screens, which will be available in Australia in October 2013. |
| Contact Information |
07 3339 3936 - Maquet Australia Service |