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
    14991
  • Event Initiated Date
    2013-07-12
  • 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
    Sample couch parameter files are supplied with monaco release 3.100 and later. the user can then access these files from the treatment couch library.By clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the "save as treatment couch" to enter a unique name for the modified couch parameter file., when sample couch parameter files are edited, the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, the modified couch densities in these samples will be overwrittem with the default value of 1.000.
  • Action
    Manufacturer to issue advice regarding use

Device

Elekta Monaco Radiation Treatment Planning System
  • Model / Serial
    Model: , Affected: , Software version: 3.100 and later
  • Manufacturer
    Elekta Inc

Manufacturer

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