Events

Recall of Varian VariSource TM iX Console software with magnetic hard disk drive only

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Varian Medical Systems Haan GmbH.

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
    18584
  • 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • Reason
    Varisource ix console software version 1.2, build 2.4336 will occasionally freeze during the treatment initiation sequence. an application freeze is a condition when, after pressing the deliver treatment button the the treatment delivery strip, the treatment delivery strip becomes blank and the afterloader remains in idle mode and does not switch to treatment delivery mode. no other buttons on the control software user interface will respond. as a consequence of a system freeze there is the potential for the partial fraction generated by the system to be incorrect.
  • Action
    Software to be upgraded

Device

Varian VariSource TM iX Console software with magnetic hard disk drive only

Manufacturer

Varian Medical Systems Haan GmbH