Events

Recall of Monaco RTP

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
    20688
  • Event Initiated Date
    2016-10-05
  • 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 creating 3d plans using either mu or dose weighting modes, if the user changes the physician's intent rx dose and the number of fractions, and then modifies the wedge angle, the mu value is scaled incorrectly. the scaling of the mu is in direct proportion to the fractional change.
  • Action
    Software to be upgraded

Device

Monaco RTP
  • Model / Serial
    Model: , Affected: Creating 3D plans and Motorized Wedges, Software version: V5.10 or V5.20
  • Manufacturer
    Elekta Inc

Manufacturer

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