Events

Recall of Monaco Image Statistics Tool

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
    17909
  • Event Initiated Date
    2014-12-22
  • 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 a ct phantom is scanned and the images are transferred to monaco, it is possible to sample the densities using the image statistics tool in monaco. in the case where ct slice thickness is not the same as ct slice spacing the image statistics tool will report an incorrect hu. if the user bases their ct to ed file on this incorrect density information, dose calculation errors will result. the magnitude of the dose calculation error will be dependent on the magnitude of the hu error.
  • Action
    Software to be upgraded

Device

Monaco Image Statistics Tool
  • Model / Serial
    Model: Monaco, Affected: , Software version: Rel 3.30 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

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