| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00917-1 |
| Product Name/Description |
Tegris OR Table Control (Operating room device management system)
Part number: 1703.35A0
All software versions up to 2.1.x.x are affected
ARTG Number: 185134 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
MAQUET has identified a potential issue that might occur with the TEGRIS software module for operating room (OR) table integration. The fault is only relevant for customers with a license for the OR Table Control 1703.35A0 module and use it to integrate the MAGNUS operating table system.The button commands for "Lower Leg up" and "Leg down" have been switched in the software for the integration of the MAGNUS operating table system. As a result, when these functions are activated on the TEGRIS touchscreen, the wrong movement is executed. Thus far, no incidence has been reported in which a person has been injured or endangered. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet Australia is advising the customers to discontinue using the Tegris OR Table Control in conjunction with MAGNUS that is equipped with a software version up to 2.1.x.x,. The problem has been resolved as of version 2.2.x.x. A Maquet Service Technician will provide a software update to resolve this issue. This action has been closed-out on 18/03/2016. |
| Contact Information |
07 3339 3936 - Maquet Australia |