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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01283-1
Product Name/Description ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning

ARTG Number: 187299
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/10/2017
Responsible Entity Elekta Pty Ltd
Reason/Issue Elekta has become aware of the potential for incorrect DICOM mapping of the exported collimator or couch angles from ERGO. This would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
If the DICOM export values are not mapped correctly, it is possible that treatments could be delivered with the wrong collimator or couch angle. In the event patients were treated with the wrong collimator or couch angle, this would result in a geometric miss with the tumour being potentially under-dosed and normal structures overdosed.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is advising users who are using MLC for dose planning in ERGO to run a verification test to ensure that the collimator and couch are rotating correctly. If the verification test fails please contact the Elekta Care Support Centre for assistance.

This action has been closed out on the 20/11/2018.
Contact Information 02 8907 1800 - Elekta