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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00667-1
Product Name/Description All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads

ARTG Number: 111760
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 3/07/2013
Responsible Entity Elekta Pty Ltd
Reason/Issue Elekta has advised that some Digital Accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta are asking users to check all affected machines against the default auto-tracking settings. A software update will be provided as a permanent fix. This action has been clsoed-out on 01/02/2016.
Contact Information 02 8907 1800 - Elekta Regulatory Affairs