| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00532-1 |
| Product Name/Description |
Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)
Software version 4.5.1 b138
ARTG number: 165040 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
After the mandatory upgrade of XVI systems from XVI R4.5 to R4.5.1 (TGA reference: RC-2012-RN-00456-3), Elekta has found that some customers are still operating on the incorrect software build of the XVI R4.5.1 b138 software. The correct build is R4.5.1 b141.
The software update from R4.5 to R4.5.1 (TGA reference: RC-2012-RN-00456-3) was to permanently correct a software problem that prevents the operation of the database reindex function and also, prevents the error that incorrectly causes a kV gating inhibit during segmental VolumeView. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If XVI Release 4.5.1 b141 is displayed on the logon screen, no further action is required. If XVI Release 4.5.1 b138 is displayed end users must contact their service representative immediately. Instructions to complete the upgrade to the correct software build are also being provided to end users. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |