| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00140-1 |
| Product Name/Description |
Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)
ARTG Number: 186856 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
When an arc based plan is created, the beam will have a default "rotation_start" angle. If the start angle for the arc is edited and then the plan delivery type is changed to a non-arc beam, the rotation start angle does not update as it should. The result is that the beam is displayed at the 'gantry' angle, but the dose is calculated at the "rotation_start" angle. If the patient is treated at this beam gantry angle, the patient will not receive the dose that the treatment planning system has calculated and displayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The problem was introduced in Monaco Release 3.20.00. The issue is resolved in the Monaco 3.20.02 Patch Release and in Monaco Release 3.30.00. Elekta is asking customers to download software fix from its website. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |