Events

Recall of Elekta Focal Radiation Therapy Treatment Planning Systems

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
    17182
  • Event Initiated Date
    2014-08-15
  • 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
    When dicom exporting an arc plan (vmat, dynamic conformal or 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan., the problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. cfs is designed to combine arcs into a single beam to streamline delivery. however, under these specific circumstances, the start and stop points for the arcs become corrupted.
  • Action
    Software to be upgraded

Device

Elekta Focal Radiation Therapy Treatment Planning Systems
  • Model / Serial
    Model: , Affected: , Software version: Focal 4.7 and 4.8 when using Elekta or Siemens linacs
  • Manufacturer
    Elekta Inc

Manufacturer

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