| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01493-1 |
| Product Name/Description |
Monaco V 5.00 and higher (Radiation therapy treatment planning system software)
ARTG Number: 215960 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. If the CT data contain slices that occur at positions of xx.x50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimisation and calculation of dose. Unloading and reloading the patient data corrects the problem.
Incorrect structure volumes can be used during optimisation. Incorrect electron densities can be assigned to some regions of the patient.This can result in incorrect dose calculations. Dose errors of greater than 5% can occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This problem will be resolved in Monaco release 5.30 and in patches to Monaco releases 5.10 and 5.11. In the interim, the problem can be avoided if the user takes the following action:
- Following contour edits, perform an “Unload All” and reload the plan prior to performing dose calculation. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 8907 1800 - Elekta |