Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14121
Brand Name:Elekta XVI Volume Imaging System
Model:
Affected:Software versions; R3.5.1, R4.2.1, and R4.5.1
Software version:
Recalling Organisation:Elekta Pty Limited - New Zealand Branch
Suite 302, Geyser Building, 100 Parnell Road
Parnell
AUCKLAND 1052
Contact Information:0273-544-793
Manufacturer:Elekta Limited (England)
Issue:In some treatment planning systems, you 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 you 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 type:Alert
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:22/1/2013
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