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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 Elekta Pty Ltd
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