Events

Recall of CLINAC 2100C HIGH ENERGY 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
    27100
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-12
  • 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
    A problem could occur where user may calibrate collimator angle position readout in reverse switching the 90 degree and 270 degree positions. this could cause patient treatment with the wrong collimator angle for any collimator angle other than 0 degrees iec. a reversed calibration could cause any attempt to perform a remote auto motion of the collimator to result in a failure to reach the target position. in this case the collimator would rotate in the direction opposite the proper direction to reach the target angle and would reach the mechanical limit before reaching the target angle.

Device

CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: H290285); Model Catalog: TRILOGY (Lot serial: >10 Serial numbers.); Model Catalog: TRILOGY (Lot serial: Contact manufacturer.); Model Catalog: 2100C (Lot serial: >10 Serial numbers.); Model Catalog: 6EX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 Serial numbers.); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: 600C (Lot serial: >10 Serial Numbers.); Model Catalog: 6EX (Lot serial: >10 Serial Numbers.); Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: 600C (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 Serial numbers.)
  • Product Description
    CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.