| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00612-1 |
| Product Name/Description |
HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)
ARTG Number: 187340 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The iGUIDE key allows to the treatment of patients without using the HexaPOD evo RT System. When users turn the iGUIDE key to the OFF position; the EXTERNAL INHIBIT signal is overridden and the iGUIDE software closes any open fractions and logs off (login appears). In some circumstances, a bug in the iGUIDE software prevents the iGUIDE software from logging off. The iGUIDE software looks like it can be used for positioning, but it is no longer running correctly. Even when users turn the iGUIDE key back to the ON position, it will not set the EXTERNAL INHIBIT signal or alert them if the position has changed (ie, Position Guard is inactive). This problem can lead to clinical mistreatment if the user assumes that the iGUIDE software is running correctly. The iGUIDE software will not set the EXTERNAL INHIBIT signal or notify the user in case of incorrect positioning or movements.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. A software update will be implemented on all affected systems that corrects the behaviour of the iGUIDE software. This action has been closed-out on 11/02/2016. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |