Events

Recall of CLINAC IX RADIO THERAPY DELIVERY SYSTEM

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
    66785
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-10
  • 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
    The auto "goto" or auto "setup" functions in c-series version 7 software ignore couch angle exceeded motion zone unless a tolerance is defined by the user (gantry rotation exclusion now only applies by default if obi is present and deployed. customer facilities using both c-series version 6 & 7 may get confused because couch safety zone no longer exists by default in v7.

Device

CLINAC IX RADIO THERAPY DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: IXS (Lot serial: manufacturer.); Model Catalog: TRILOGY (Lot serial: manufacturer.); Model Catalog: IX (Lot serial: >10 units. Contact); Model Catalog: IXS (Lot serial: >10 units. Contact); Model Catalog: TRILOGY (Lot serial: >10 units. Contact); Model Catalog: IX (Lot serial: manufacturer.); Model Catalog: 21EX (Lot serial: >10 units. Contact); Model Catalog: 21EXS (Lot serial: >10 units. Contact); Model Catalog: 21EXD (Lot serial: >10 units. Contact); Model Catalog: 2100C (Lot serial: manufacturer.); Model Catalog: 21EXD (Lot serial: manufacturer.); Model Catalog: 21EXS (Lot serial: manufacturer.); Model Catalog: 21EX (Lot serial: manufacturer.); Model Catalog: 2100C (Lot serial: >10 units. Contact); Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: IXS (Lot serial: H294750); Model Catalog: IX (Lot serial: H294750); Model Catalog: IXS (Lot serial: H294551); Model Catalog: IX (Lot serial: H294551); Model Catalog: IXS (Lot serial: H294403); Model Catalog: IX (Lot serial: H294403)
  • Product Description
    CLINAC IX RADIO THERAPY DELIVERY SYSTEM
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.