Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16598
Brand Name:RaySearch RayStation Radiation therapy treatment planning system 4.0
Model:
Affected:
Software version:Version 4.0.3.4
Recalling Organisation:CARSL Consulting
30 Fulford Road
Havelock North 4130
Hastings
Contact Information:09 238 3447
Manufacturer:RaySearch Laboratories AB (publ)
Issue:There is a potential problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI (region of interest) can be wrong. This affects all dose-volume properties for such ROIs, including DVH (dose-volume histogram), dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:30/4/2014
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