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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00651-1
Product Name/Description Monaco software versions 5.10.00 and higher

ARTG Number: 215960
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 25/05/2016
Responsible Entity Elekta Pty Ltd
Reason/Issue When DICOM is exporting a 3D Monaco plan and the “Composite Field sequencing” (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. This occurs when the port shape used to define or edit the MLC positions extends beyond or inside the actual jaw positions. The defect is triggered when using a workflow for Forward Planning IMRT that involves creating multiple beams for the same gantry angle with a single MLC shape defined for each beam. These beams are then exported using CFS to combine the individual 3D beams into a single IMRT beam sequence.

The planned and approved dose distribution will not agree with the dose delivered. This deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the MLC shape is drawn outside or inside of the collimator jaws. There is a remote probability that serious injury could occur.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction. This action has been closed-out on 09/05/2017.
Contact Information 02 8907 1800 - Elekta