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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00844-1
Product Name/Description Leksell GammaPlan 11.1

ARTG Number: 158043
(Elekta Pty Ltd - Radionuclide system, therapeutic, stereotactic radiosurgery, application program software)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/07/2018
Responsible Entity Elekta Pty Ltd
Reason/Issue Elekta has identified that the margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

The root cause is that the margin algorithm calculates the expanded volume at a resolution limited to the original images resolution in the contours normal direction, resulting in an overestimation of the resulting margin volume in areas oblique to the contouring plane.
Recall Action Product Defect Correction
Recall Action Instructions Elekta is requesting users consider implications of the described inaccuracy in use of the margin tool in Leksell GammaPlan.

This action has been closed out on the 26/11/2018.
Contact Information 02 8907 1800 - Elekta