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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00051-1
Product Name/Description Monaco (with the use of Elekta Motorised Wedges)

Software versions:
V 5.10.00 (including 5.10.01, 5.10.02)
V 5.11.00 (including 5.11.01)
V 5.20.00

ARTG Number: 215960
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/01/2017
Responsible Entity Elekta Pty Ltd
Reason/Issue An issue has been identified where the calculated dose from wedged beams can be assigned to the wrong beam. This can occur for a plan with at least two beams using the Elekta motorised wedge. As a consequence, a geometric miss would result with the dose distribution not reflecting what is delivered to the patient.
Recall Action Recall for Product Correction
Recall Action Instructions As a temporary fix, Elekta is advising users to change the beam index numbers belonging to the two wedged beams, such that the index numbers are exchanged for these beams, then edit the wedge angle of one of the beams. The problem will resolve itself if a recalculation is forced after the beam numbers are edited and the wedge angle is modified, A permanent fix in the form of a software update is anticipated to be released by the end of May 2017.
This action has been closed out on the 12/10/2018.
Contact Information 02 8907 1800 - Elekta