Events

Recall of CLINAC IX 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
    95992
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-23
  • 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
    Under certain conditions photon beams in high energy clinacs may experience a gradual change in beam symmetry potentially reaching an asymmetry of up to approximately 7 % before interlock occurs. at maximum asymmetry this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam. the type of asymmetry normally results in a beam which is higher than desired on one side of the central axis lower on the other side and approximately correct at the central axis. asymmetry value as used here means the peak to peak (over to under) differences observed. therefore a maximum asymmetry of 7% will result in a dose deviation of no more than 3.5% at any point in the beam with a smaller deviation near the central axis of the beam. normally the central axis dose values represent the calibration point and are not affected.

Device

CLINAC IX HIGH ENERGY LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: CLINAC IX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: TRILOGY (Lot serial: H294991); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: 2100C (Lot serial: H270838); Model Catalog: 2100C (Lot serial: H270544); Model Catalog: 2100C (Lot serial: H270823); Model Catalog: 2100C (Lot serial: H271161); Model Catalog: 2100C (Lot serial: H270708); Model Catalog: TRILOGY (Lot serial: H291166)
  • Product Description
    Clinac IX High Energy Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.