Events

Recall of TRILOGY 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
    133448
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-16
  • 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
    An event occurred with c-series clinac accelerator. the event entails excessive connector resistance which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. normal morning daily quality assurance testing and light field verification detected the discrepancy. investigation found that a similar issue could arise on the gantry or couch axes. this does not affect the mlc.

Device

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

Manufacturer

VARIAN MEDICAL SYSTEMS INC.