| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00105-1 |
| Product Name/Description |
Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11
Version 11 with PBC 11.0.21, 11.0.30
Product Code: H48
ARTG Number: 119983 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
The final calculated dose of dose dynamic fields will be incorrect when both conditions occur:
1. The Pencil Beam Convolution [PBC] 11 algorithm license feature is used,
2. Either the energy and/or the treatment unit of a dose dynamic field, differs from
that of the first created treatment field in the plan.
Under these conditions, the final dose calculation will determine the MU to dose calibration (MUGy10) factor and the applicable Dose Rate table value (CSBF coefficient) using the energy of the first treatment field (in the order of creation) for all dose dynamic fields, regardless of the actual field energy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian Medical Systems is requesting users to not use the Pencil Beam Convolution (PBC) 11 algorithm for dose dynamic plans. It is recommended that dynamic MLC plans are calculated with the AAA or Acuros XB algorithm. PBC versions prior to version 11 can still be used.
Varian recommends a review of treated patient plans where the PBC 11 algorithm was used for the calculation of dose dynamic plans.
A technical correction is under development and will be implemented once complete. |
| Contact Information |
1800 657 036 - Varian Oncology Helpdesk |