Events

Recall of Varian C-Series High Energy Linear Accelerator

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
    16913
  • Event Initiated Date
    2014-07-04
  • 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
    Varian has received several reports of unexpected beam output variations with the c-series high energy [he] linear accelerator for 6mv photon treatment mode. the issue has been reported for versions 7, 8 and 9 with 6 mv configuration and maximum dose rate of at least 600 mu/min only. it was determined during intensive investigation that the 6mv target had developed a cavity or hole. degradation of the target led to beam output and symmetry changes which were not detected by the linear accelerator. the result is that a lower than intended dose could be delivered to the target volume if treatment were to take place. varian has not received any report of misadministration or injury due to this 6mv target degradation or failure.
  • Action
    Software to be upgraded

Device

Varian C-Series High Energy Linear Accelerator
  • Model / Serial
    Model: Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300 C/D, Clinac DHX, Clinac 21EX, Clinac 23EX, Affected: , Software version: Version: 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc