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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01356-1
Product Name/Description Focal Release 4.80.00

ARTG Number: 186853
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/12/2014
Responsible Entity Elekta Pty Ltd
Reason/Issue When a CT phantom is scanned and the images are transferred to Focal, it is possible to sample the densities using the Image Statistics tool in Focal. In the case where CT slice thickness is not the same as CT slice spacing the Image Statistics tool will report an incorrect HU. If the user bases their CT to ED file on this incorrect density information, dose calculation errors will result. The magnitude of the dose calculation error will be dependent on the magnitude of the HU error.

This problem can only occur for sites who satisfy ALL of the below criteria:
1. Running Focal Release 4.80.00
2. Using a CT Slice Spacing not equal to the CT Slice Thickness, and
3. Using the Image Statistics Tool to quantify CT phantom densities which are then used to populate the CT to ED file.

There have been no patient injuries reported.
Recall Action Recall for Product Correction
Recall Action Instructions As an immediate workaround:- The problem can be avoided by using a CT Slice Spacing equal to the CT Slice Thickness; and
A software fix will be provided to rectify the defect as soon as possible.
This action has been closed-out on 28/02/2018.
Contact Information 02 8907 1800 - Elekta Pty Ltd