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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 Elekta Pty Ltd
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