| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01187-1 |
| Product Name/Description |
Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (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 |
11/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
In rare cases the XVI can incorrectly calculate the target position of the treatment table. The sequence of events when this error occurs is:
- The user does an online VolumeView acquisition and registration
- The user accepts the registration and the Table Move Assistant dialog box appears
Two different scenarios can result:
- If the issue occurs only during initial patient set up the Absolute Actual column of the Table Move Assistant dialog box incorrectly shows blank values. This error can cause a collision between the patient and the external beam limiting device but mistreatment cannot occur as it is not possible to get the Table Move Assistant values in tolerance.
- If the issue occurs at times other than initial patient set up the Absolute Actual column of the Table Movement dialog can display incorrect values. There is potential for clinical mistreatment if the Relative Set value is less than 01.cm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising all affected users of the mandatory software upgrade which will prevent table movement if the start position has not been recorded correctly. A permanent solution for this problem is now available for all customers running XVI 5.0.0, XVI 5.0.1 systems. An Elekta service team member will contact the customers to install the software upgrade. This action has been closed-out on 07/06/2016. |
| Contact Information |
02 8907 1800 - Elekta Pty Ltd |