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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00954-1
Product Name/Description MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)

ARTG Number: 225164
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/07/2016
Responsible Entity Elekta Pty Ltd
Reason/Issue It is possible that a change to an Order Set will not be saved in the current, open Care Plan when the following workflow is utilised:

1. Open either the Care Plan Edit form or the Care Plan Instance form and leave the form open.

2. Select an Order Set that is part of the same Care Plan and make a change to the Order Set. This can be a change to the Order Set name or label or a change to the drug, dose, administration instructions, etc.

3. The update made to the Order Set will NOT be saved in the current, open Care Plan.

Although drug and/or dose information could be edited, but if substantial changes were made to drug information a new Order Set would be generated rather than editing an existing Order Set. It is more likely that the edits made would result in non-serious injury (such as administration details, Order Set name, etc.) There have been no injuries reported as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is advising users to ensure all Care Plan windows are closed prior to making and updates to Order Sets. A software correction will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.
Contact Information 02 8907 1800 - Elekta