| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00466-1 |
| Product Name/Description |
MAGNUS Hybrid OR table column 1180.01B2
Serial Numbers: 00001 to 00100
ARTG Number: 163023 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Maquet have been made aware of a complaint regarding a reported collision between the C-arm of the angiography-system and the MAGNUS OR table system.
The root cause analysis has shown that the MAGNUS column provided the wrong position data for the longitudinal movement. Thus the collision calculation of the angiography-system led to an incorrect result.
It was diagnosed that the MAGNUS OR table system may provide incorrect position data for particular movements in very rare cases after switching on the angiography-system. If this occurs, the system at the latest operates properly again after activating the corresponding movement. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A MAQUET service technician will be contacting users to arrange an appointment to update the software free of charge.
Until that occurs users should activate all movements of the OR table system for a short time after switching on the angiography-system. The operator always has to observe the movement of the C-arm to have the possibility to react early enough if required.
This action has been closed out on the 17/10/2018. |
| Contact Information |
1800 605 824 - MAQUET Australia |