Events

Recall of ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

According to Health Canada (via FOI), this recall involved a device in Canada 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
    55961
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Unexpected auxiliary device authorization - two successive ready signals from exactrac to 4ditc through auxiliary device interface will unexpectedly clear both exactrac interlock and the bccv interlock on the linac.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Model / Serial
    Model Catalog: V8.8 (Lot serial: 4DITC version 10); Model Catalog: V8.8 (Lot serial: 4DITC version 11)
  • Product Description
    4D Integrated Treatment Console
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.