Events

Recall of Medical Intelligence HexaPOD evo RT System

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
    21356
  • Event Initiated Date
    2017-04-28
  • 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
    If by mistake the initial pre-treatment imaging was performed before the hexapod was moved to the drive (start) position, iguide offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. this should avoid the need to redo imaging with hexapod in drive (start) position. in this scenario the software may prompt you several times to move the hexapod to its drive (start) position.
  • Action
    Software to be upgraded

Device

Medical Intelligence HexaPOD evo RT System

Manufacturer

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