| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01116-1 |
| Product Name/Description |
iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment)
ARTG Number: 187340 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
iGUIDE monitors if the HexaPOD is in the pre-defined 3D position. If it is not in this position an inhibit is set. For 3D treatments there is no iGUIDE Interlock Check possible. In the event of a malfunction of the interlock system an inhibit in iGUIDE may not lead to an External Inhibit on the Linac. There is the potential for unrecognised incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising user that if users do not intend to use iGUIDE for patient positioning, make sure the HexaPOD is at its pre-defined 3D position before treatment. The 3D position is confirmed in the iGUIDE login screen (no inhibit icon) or in the iGUIDE System Overview. In addition the External Inhibit LED at the Enable Switch Board must be off. It is recommended to perform the Interlock Check in the iGUIDE software on a daily basis. This information has been included in the Instructions For Use (IFU). This action has been closed-out on 09/05/2017. |
| Contact Information |
02 8907 1800 - Elekta |