Events

Recall of CLINAC 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
    83321
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-15
  • 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
    On clinacs running c- series version 7.X the couch can be moved via the float mode when the stereotactic motion disable function is turned on. this may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal.

Device

CLINAC LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX H14 (Lot serial: > than 10 serial numbers.); Model Catalog: CLINAC IX H27 (Lot serial: > than 10 serial numbers.); Model Catalog: 21EXS (Lot serial: > than 10 serial numbers.); Model Catalog: 2100C (Lot serial: > than 10 serial numbers.); Model Catalog: 21EXS (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX H27 (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX H29 (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX H14 (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX H29 (Lot serial: > than 10 serial numbers.)
  • Product Description
    Clinac IX Radio Therapy Delivery System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.