Events

Recall of Nucletron Oncentra Brachy Planning System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Nucletron BV.

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
    18590
  • Event Initiated Date
    2015-05-28
  • 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: Nucletron Pty Ltd, C/O Alpha Customs Services Ltd, 67 Vivian Street, New Plymouth 4310
  • Reason
    In oncentra brachy (brachy planning (bp) module and plan analysis (pa) module) dose may be incorrectly calculated for regions of interest (rois) defined on a secondary image series when using specific registration methods., the magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value.
  • Action
    Software to be upgraded

Device

Nucletron Oncentra Brachy Planning System
  • Model / Serial
    Model: , Affected: , Software version: 3.x (excluding v3.0) and 4.x
  • Manufacturer
    Nucletron BV

Manufacturer

Nucletron BV
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA