| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01087-1 |
| Product Name/Description |
syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)
ARTG Number: 181846 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens are advising users regarding a bundled update of the syngo RT Oncologist software. The update addresses the following issues:
- Incorrect offset calculation in Adaptive targeting Option. In rare cases, an identical Region of Interest (ROI) label for the planning isocenter and the treatment isocenter may have been randomly generated during image processing. In this case the offset calculation in Adaptive Targeting during image review has been incorrect.
- Problems with structure name in case of using structure operation functionality in Segmentation. In special scenarios within the Structure Operation functionality of the Segmentation tab, the system did not store the selected name from the list of predefined names when creating a new structure. After reloading the data, the system replaced the name of this structure by the name of the former last deleted structure.
There have been no reports of injuries as a result of the reported issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users of the potential issues in order for users to maintain awareness until the software correction is implemented as a permanent correction. This action has been closed out on 16 June 2017. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |