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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01291-1
Product Name/Description Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)

ARTG Number: 214673
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 3/12/2013
Responsible Entity Elekta Pty Ltd
Reason/Issue XVI can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently.

If the user does not monitor the patient and treatment table movements, and keeps the Table Automatic Setup (ASU) buttons pressed, the treatment table continues to move potentially resulting in a fatal collision with the patient. It only stops when a touchguard activates. This error can cause a collision between the patient and an external beam limiting device (BLD) if:
- the external BLD does not operate with the touchguard attached, or
- the external BLD extends out more than the touchguard.

When the error occurs, it is not possible to get the table Move Assistant values in tolerance. Therefore, it is not possible to apply an incorrect correction to the patient position before treatment delivery.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is providing work around instructions for users to follow. Elekta is advising users to monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the function keypad (FKP). To correct the error, users are advised to restart the XVI, place patient in initial set up position and scan the patient again and continue the usual workflow. A software update is expected to be released in April 2014 for upgrading all XVI 4.2.1 users to XVI 4.2.2 to resolve this issue. This action has been closed-out on 17/05/2017.
Contact Information 02 8907 1800 - Elekta Regulatory Affairs