| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00652-3 |
| Product Name/Description |
Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11
Multiple Serial Numbers affected
Product Code: H48
ARTG Number: 119983 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
A software anomaly has been identified with the Eclipse Treatment Planning System where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimisation, the Monitor Units and dose distribution may not reflect the intended prescription. |
| Recall Action |
Recall |
| Recall Action Instructions |
Varian is recommending users to implement work around instructions until a software fix is developed and implemented. |
| Contact Information |
1800 657 036 – Varian Oncology Helpdesk |