Recall of 4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)

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-2014-RN-00947-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-29
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 received two reports from customers with c-series linear accelerators (linac) used with varian’s barcode conical collimator verification system (bccv) and brainlab’s exactrac patient positioning system where the user was able to clear the interlock for bccv, imposed by the 4ditc, from the exactrac console. in both reported cases, the user was employing a c-series he linac with 4ditc and both exactrac and bccv. the user was authorising the exactrac to the linac 4ditc. successive signals were sent from the exactrac to the 4ditc. the first signal cleared the exactrac interlock as intended. the exactrac console requested user confirmation of the second command to authorise. the user responded affirmatively. the signal was sent to the 4ditc, and the linac interlock associated with bccv was released. in such a situation, it may be possible to irradiate the patient using a cone other than what is specified by the treatment plan because the bccv verification was not completed.
  • Action
    Varian is reminding users of the correct procedures using auxiliary devices requiring the ADI interface and is providing recommended verification steps when carrying out treatment i.e., stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A permanent fix has been developed and a Varian representative will schedule the installation. This action has been closed-out on 12/08/2016.

Device

  • Model / Serial
    4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)Product code: H51Serial Numbers: H514278, H514544, H515102, H51B568, H513894, H515619 & H51B100ARTG Number: 116839
  • Product Classification
  • Manufacturer

Manufacturer