Events

Recall of Elekta Digital Accelerators

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Elekta Limited (England).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    14944
  • Event Initiated Date
    2013-07-05
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Reason
    Elekta is aware that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults., increasing auto-tracking values from factory-set defaults goes against elekta recommendations and can result in the system becoming non-compliant with iec standards, in particular with the safety standard iec 60601-2-1.
  • Action
    Software to be upgraded

Device

Elekta Digital Accelerators
  • Model / Serial
    Model: All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads, Affected: All serial numbers
  • Manufacturer
    Elekta Limited (England)

Manufacturer

Elekta Limited (England)
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA