Events

Recall of Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators

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
    15626
  • Event Initiated Date
    2013-11-06
  • 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
    Events have been reported in which a user has remotely rotated the gantry into contact with the couch or with patients, in both the manual mode and the automated mode. in one event, a patient was reported injured when the user operating the gantry in manual mode, rotated the gantry of a clinac® 21ex into physical contact with the patient's pelvis. this event involved use of remote manual control of gantry rotation (i.E. controlled manually from outside the treatment vault). such a motion is not a preprogrammed motion and is exclusively under the control of the operator.
  • Action
    Software to be upgraded

Device

Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators
  • Model / Serial
    Model: Product Codes: H14, H18, H27, H29, Affected: Versions: 7.x, 8.x, 9.0
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc