| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01287-1 |
| Product Name/Description |
X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (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 |
2/12/2013 |
| Responsible Entity |
|
| 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. 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 if the external BLD extends out more than the touchguard. If the error occurs, fatal injury to the patient could occur. 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 will be released for upgrading all XVI R4.5, R4.5.1, R4.6 users to XVI 5.0. A fix to resolve the issue will be developed for XVI R5.0 which is estimated for completion in December 2014.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |