Events

Recall of Elekta HexaPOD evo RT System, iGUIDE 2.0

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medical Intelligence Medizintechnik GmbH.

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
    16780
  • Event Initiated Date
    2014-06-05
  • 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
    The iguide key allows you to treat patients without using the hexapod evo rt system. when you turn the iguide key to the off position:, · the external inhibit signal is overridden., · the iguide software closes any open fractions and logs off (login appears)., in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when you turn the iguide key back to the on position, it will not set the external inhibit signal or alert you if the position has changed (position guard is inactive).
  • Action
    Software to be upgraded

Device

Elekta HexaPOD evo RT System, iGUIDE 2.0

Manufacturer

Medical Intelligence Medizintechnik GmbH
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA