Events

Recall of Varian Eclipse Treatment Planning Program

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 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
    19673
  • Event Initiated Date
    2016-01-19
  • 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
    Manufacturer has received a report of an anomaly involving eclipse™ treatment planning system pencil beam convolution (pbc) 11.0.31 to compute a conventional arc dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11, 13, 13.5 or 13.6, the displayed dose does not correspond to the calculated monitor units (mu). varian has not received any report of misadministration due to this issue.
  • Action
    Software to be upgraded

Device

Varian Eclipse Treatment Planning Program

Manufacturer

Varian Medical Systems Inc