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
    51828
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-20
  • 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
    Collimator cover is falling from the linear accelerator. it appears the collimator cover was not properly installed and that motion of the linear accelerator caused the cover to detach and fall from the machine. it was determined that the collimator latching mechanism may be difficult to latch properly resulting in an increased likelihood of accidental detachment of the collimator cover.

Device

CLINAC LINEAR ACCELERATOR
  • Model / Serial
    Model Catalog: 6EX (Lot serial: H180605 (600C Unit)); Model Catalog: 600C (Lot serial: H180600 (600C Unit)); Model Catalog: 6EX (Lot serial: H180796 (6EX Unit)); Model Catalog: 600C (Lot serial: H180796 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180683 (6EX Unit)); Model Catalog: 600C (Lot serial: H180683 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180619 (6EX Unit)); Model Catalog: 600C (Lot serial: H180619 (6EX Unit)); Model Catalog: 6EX (Lot serial: H272910 (6EX unit)); Model Catalog: 600C (Lot serial: H272910 (6EX unit)); Model Catalog: 6EX (Lot serial: H293787 (600C Unit)); Model Catalog: 600C (Lot serial: H293787 (600C Unit)); Model Catalog: 6EX (Lot serial: H291180 (600C Unit)); Model Catalog: 600C (Lot serial: H291180 (600C Unit)); Model Catalog: 6EX (Lot serial: H180600 (600C Unit)); Model Catalog: 600C (Lot serial: H180605 (600C Unit)); Model Catalog: NOVALIS TX (Lot serial: H272857); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: 2100C (Lot serial: H271662); Model Catalog: 2100C (
  • Product Description
    CLINAC LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.