Events

Recall of Monaco

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
    20997
  • Event Initiated Date
    2017-01-10
  • 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
    The manufacturer has indentified that calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorized wedge. the user must change the beam index numbers belonging to the two wedged beams, such that the index numbers have been exchanged for these beams, then edit the wedge angle of one of the beams.
  • Action
    Manufacturer to issue advice regarding use

Device

Monaco
  • Model / Serial
    Model: , Affected: Running Monaco: V 5.10.00 (including 5.10.01, 5.10.02), or V 5.11.00 (including 5.11.01), or V 5.20.00, and Using Elekta Motorized Wedges
  • Manufacturer
    Elekta Inc

Manufacturer

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