Recall of NOVALIS TX LINEAR ACCELERATOR

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
    90805
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-30
  • Event Country
  • 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
    Anomalies have been identified with the clinac collimator and couches that can result in small patient or field positioning errors that may adversely affect high - dose treatments requiring small positioning tolerances such as stereotactic radiosurgery (srs) and stereotactic radiotherapy (srt). refer to 'c- series clinacs when used for hypo-fractioned radiotherapy' dated 06/23/2010 for further information.

Device

  • Model / Serial
    Model Catalog: (Lot serial: manufacturer); Model Catalog: (Lot serial: >10 units. Contact); Model Catalog: (Lot serial: manufacturer.)
  • Product Description
    Novalis TX Linear Accelerator
  • Manufacturer

Manufacturer