Events

Recall of Elekta Monaco Radiation 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
    19289
  • Event Initiated Date
    2015-10-21
  • 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
    Two identified issues:, 1- in version 5.10.01, the isodose control 100% isodose value was linked to the dose normalization value so users would always have a known normalization value linked to 100% when in relative mode. this however limits the user to only one defined value available above 100%. when the 100% isodose value is edited on the isodose control, the dose normalization is automatically updated. if the user does not notice this update and then rescales to a relative isoline and does not read the dose normalization value displayed on the rescale bar, the rescale could be other than intended., , 2-when the user optimizes, then changes the bolus assignment of the beams, and then selects "calculate" (not "optimize" again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect for the bolus assignment of the beams.
  • Action
    Software to be upgraded

Device

Elekta Monaco Radiation Treatment Planning System
  • Model / Serial
    Model: , Affected: , Software version: 5.10 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

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