| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00275-1 |
| Product Name/Description |
XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)
ARTG Number: 99769 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Dose and Monitor Unit values are not computed correctly when Elekta Motorised Wedges are used with Dynamic Conformal arcs. The problem occurs because only the start and stop angles of the Dynamic Conformal arcs are computed when all sub-beams of the arc should be computed. The planned dose distribution will not reflect the delivered dose. Some anatomical structures will receive more dose than the plan reflects, some will receive less dose. It is possible that the target could likewise receive more or less dose than what is reflected in the plan. There is a remote probability of a mistreatment resulting in serious injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that the problem can be avoided by not using Elekta Motorised Wedges with Dynamic Conformal arcs. The problem was introduced in XiO Release 4.1 and will be resolved in Release 5.00.01 which will be released by March/April 2014. |
| Contact Information |
02 8907 8100 - Elekta Regulatory Affairs |