Events

Recall of Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Varian Medical Systems Australasia Pty Ltd.

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
    RC-2012-RN-00852-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00852-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Varian is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
  • Action
    Onsite inspection and replacement of jaw carriers. This action has been closed-out on 18/02/2016.

Device

Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radi...
  • Model / Serial
    Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)Product codes: H14, H18, H29Affected Serial Numbers: H140865, H140898, H140899 and H294667ARTG Number: 116839
  • Product Classification
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd