| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01091-1 |
| Product Name/Description |
Monaco with software versions 3.1 and higher (Radiation therapy treatment planning system)
ARTG Number: 215960 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner. If the patient is not saved and recalled, in a subsequently created plan the BEV will show the contours as still present while the Transverse, Sagittal and Coronal views will show the contours as deleted. The total volume of the structure reported in the DVH and the Structure Control will not match. If the study set is saved and reopened before plan creation the total volume of the structure reported in the DVH and the Structure Control will be corrected. A similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.
If the user bases their clinical decisions on incorrect contours it could lead to dose errors and potential patient mistreatment. There have been no reports of injuries due with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising users to incorporate the one of the following steps into the general contouring workflow:
1. Delete before edit: For newly generated contours, delete any unwanted contours and save before making edits (move, rotate, reshape)
2. If further deletions are required after edits are performed, save and unload the data. Then reload the data before deleting. This will allow the affected code to locate all the coordinate points of the contour.
3. Delete Contour and start over.
4. Clear Contour and start over.
Elekta will be implementing a software upgrade as a permanent correction.
This action has been closed-out on 22/03/2018. |
| Contact Information |
02 8907 1800 - Elekta |