| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00064-1 |
| Product Name/Description |
Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) Algorithm 11.0.31
(Radiation therapy treatment planning system)
Product Code: 48
Multiple Serial Numbers
ARTG Number : 119983 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
The anomaly in PBC algorithm 11.0.31 affects Eclipse versions 11, 13, 13.5 and 13.6, for arcs consisting of more than 100 segments causing Eclipse to display a dose distribution that does not correspond to the calculated Monitor Units, which may lead to an overdose. The discrepancy is easily detectable when a phantom is used to verify the treatment plan, as advised in the user documentation. The discrepancy between the displayed dose distribution and MUs increases with the number of segments above 100. When the arc has few segments above 100, the discrepancy is smaller and more difficult to detect. As the number of segments increases above 100, the discrepancy between the displayed dose and the actual dose becomes more pronounced. When an arc is comprised of significantly more than 100 segments, the arc plan will not display MU, and the arc treatment plan will become invalid and cause the treatment to be blocked.
Varian has not received any report of mistreatment due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian Medical Systems is currently investigating a permanent solution for this issue. In the interim, users are advised to NOT USE Eclipse version 11, 13, 13.5, or 13.6 with PBC 11.0.31 algorithm for conventional arc field dose calculation. Varian recommends use of the Eclipse Anisotropic Analytical Algorithm (AAA) or Acuros XB advanced dose calculation algorithm for conventional arc field dose calculation. Users can verify whether a plan generated by Eclipse version 11, 13, 13.5 or 13.6 using PBC 11.0.31 exceeds the 100 segment limit for a given field by reviewing the calculation log files. The affected fields should be evaluated by re-calculating the plan with either: AAA, Acuros XB or PBC 10.0.28 dose calculation algorithms. For conformal arc plans, fields can also be evaluated in the properties of the dynamic MLC.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9485 0100 - Varian Medical Systems |