Events

Recall of Elekta Focal Radiation Therapy Treatment Planning System

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

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
    13117
  • Event Initiated Date
    2012-07-03
  • 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: AlphaXRT Ltd, 10 The Promenade, Takapuna, Auckland
  • Reason
    If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:, issue1: the coordinates will be in dicom space, thus not matching the setup reference dialog., issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.
  • Action
    Software to be upgraded

Device

Elekta Focal Radiation Therapy Treatment Planning System
  • Model / Serial
    Model: , Affected: Release 4.64.00
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA