| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00448-1 |
| Product Name/Description |
ONCENTRA Brachy version 3.x and 4.x
ARTG number: 142110 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
In Oncentra Brachy (Brachy Planning (BP) module and Plan Analysis (PA) module) dose may be incorrectly calculated for Regions Of Interest (ROIs) defined on a secondary image series when using specific registration methods. The magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software patch is in development to correct this issue and is expected to be released end of November, 2015. Nucletron will work with their customers to implement the patch on affected devices. In the interim, end users are advised to resample Regions of Interest defined on a secondary image series onto the primary image series prior to dose evaluation. This action has been closed-out on 4/08/2016. |
| Contact Information |
02 9517 1300 - Nucletron Pty. Limited |