Events

Recall of Oncentra RTP

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
    21821
  • Event Initiated Date
    2017-08-17
  • 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 default step size set in rdstore is typically used during the planning process. the measured source paths for a ring-type applicator always have a source step size of 2.5 mm for the microselectron afterloader. when creating an oncentra brachy plan for a ring applicator with a measured source path, the step size of the measured source path will be used for the entire plan., the issue is caused by the measured source paths for the applicators listed below, which have a source step size of 2.5 mm for the microselectron afterloader. if you use such an applicator model to create a plan, while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5 mm, while the afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
  • Action
    Software to be upgraded

Device

Oncentra RTP
  • Model / Serial
    Model: , Affected: Oncentra Brachy versions 4.5, 4.5.1, 4.5.2.
  • Manufacturer
    Nucletron BV

Manufacturer

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