The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning all Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads, manufactured by Elekta.
According to the TGA, the manufacturer 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. The manufacturer is asking users to check all affected machines against the default auto-tracking settings. A software update will be provided as a permanent fix.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00667-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 July 2013