Events

Recall of VARIS - 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
    130916
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-17
  • 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
    Malfunction when adding cbct image. present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert long lat) editing & acquiring for approved plans' selected in treatment administration. therapists can acquire gantry angle into plan even without system rights to acquire gantry angle. patient treated with wrong gantry angles one day.

Device

VARIS - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Model / Serial
    Model Catalog: 8.0.23 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.0.23 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1.1.3 (Lot serial: >10 serial numbers. Contact); Model Catalog: H51 (Lot serial: manufacturer.); Model Catalog: 8.8.0 (Lot serial: manufacturer.); Model Catalog: 8.6.2 (Lot serial: manufacturer.); Model Catalog: 8.6.1 (Lot serial: manufacturer.); Model Catalog: 8.6 (Lot serial: manufacturer.); Model Catalog: 8.3 (Lot serial: manufacturer.); Model Catalog: 8.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1.2 (Lot serial: manufacturer.); Model Catalog: 8.1.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: manufacturer.); Model Catalog: H51 (Lot serial: >10 serial numbers.
  • Product Description
    Varis 4D Integrated Treatment Console
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.