| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00802-1 |
| Product Name/Description |
iGUIDE software 2.2
(sites using iGUIDE 2.2.0 and 2.2.1)
Reference Number: FCA-MI-0003
ARTG Number 187340 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has identified that if the PEC data dialog after a verification scan is cancelled, a re-send of PEC data will lead to incorrect positioning because the 2nd PEC values supersede the 1st PEC values instead of being added. There is a risk of incorrect positioning (values of 1st PEC are overwritten). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is requesting that users do not cancel the 2nd iGUIDE PEC data dialog (and confirm the cancellation) for a verification scan. If you have cancelled the 2nd PEC data dialog, you have to restart the positioning and return to the beginning of the positioning procedure.
This action has been closed out on the 16/11/2018. |
| Contact Information |
02 8907 1800 - Elekta |