| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00560-1 |
| Product Name/Description |
MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)
ARTG Number: 206321 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
When using MOSAIQ Couch Move Assistant (CMA), if the user hovers the mouse pointer exactly above the Direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the Direction selection might change when the intention was only to move the mouse pointer to a different area of the screen. Likewise, if the user hovers the mouse pointer exactly above the Site dropdown and uses the mouse thumbwheel or touchpad scroll bar, the Site could change and the Direction and Offset will change depending on the Site selected. An inadvertent change can also occur if either the Direction or Site dropdown is selected, the mouse pointer is anywhere on the dialog, and the mouse thumbwheel or touchpad scroll bar is used. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that the problem can be avoided by moving the mouse pointer away from the Direction or Site dropdowns or by making sure these options are not selected when using the thumbwheel or touchpad scroll bar. This problem will be resolved in a future MOSAIQ software release. This action has been closed-out on 11/04/2016. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |