| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00910-1 |
| Product Name/Description |
Monaco 5.10.00
(Radiation therapy treatment planning system)
ARTG: 215960 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
1)Dose and MU Incorrect When CT Images Viewed From the Head:
CT images are typically presented as if the viewer is standing at the foot of the couch and looking toward the patient’s head. However, for Neurosurgery, images are often created as if being viewed from the top of the couch looking toward the patient’s feet. When CT images are created this latter way and imported in Monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. The dose distribution and monitor units will be incorrect.
2)Dose and MU Incorrect When Using Multiple Prescriptions With Forced Densities:
When using Multiple Prescriptions and the first prescription has forced densities, these forced densities are not being maintained with the second prescription. The dose distribution and monitor units will be incorrect as the initial prescription will use forced densities and the second prescription will use CT densities. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising customers that both problems will be resolved in Monaco Patch Release 5.10.01 which will be available for general release in late September. This action has been closed-out on 19/08/2016. |
| Contact Information |
02 8907 1800 - Elekta |