| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00074-1 |
| Product Name/Description |
XVI R3.5, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy)
ARTG Number: 165039 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
In some treatment planning systems, the users can contour more than one region of interest with the same structure name. The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. Therefore, if the user use DICOM RT to send these volumes as one list of contours, it can cause XVI to:
- Interpolate a contour that identifies the two structures as one structure.
- Change the contour shape of the volumes in the imported CT reference data and structure sets. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising users to ensure that fields are correct when importing patient data from the treatment planning system (TPS) and to give different volumes different structure names as a work around. A software release will be provided to correct the issue. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |