| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00781-1 |
| Product Name/Description |
MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)
ARTG Number: 206321 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Clicking on the Treat button in the Treatment Chart window will trigger the Plan-of-the-Day IQ script to run. The Plan-of-the-Day window will open and the treatment plan can be selected by clicking on the radio button. It is possible that the selected Plan-of-the-Day could be accidentally changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
Though the wrong Plan-of-the-Day selected for one fraction would likely not result in Critical harm, if the wrong plan were selected multiple times it could result in serious injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The issue is corrected in the general release of MOSAIQ 2.64. A software patch will be released for MOSAIQ version 2.62 in order to correct the defect. In the interim, the problem can be avoided by careful use of a mouse with a wheel (or using a mouse without a scroll wheel) and verifying that the correct plan is chosen before selecting OK on the Plan-of-the-Day form. This action has been closed-out on 02/02/2017. |
| Contact Information |
02 8907 1800 - Elekta |