Events

Recall of SEGMENTED CYLINDER SET

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
    127918
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-04
  • 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
    In the previous recall (55250) the blocking washer on the flexible probe (gm11002420) may shift and users are not to use a flexible probe with an unstable or shifted blocking washer due to potential for treatment error. this update notice supplements and modifies the previous instructions that you may continue to use the original design flexible probe with blocking washer and old design guiding tube. here users are instructed to stop using these older products (gm11002420 flexible applicabtor probe with blocking washer at 234 mm (old design) gm11005170 guiding tube for segmented cylinders (old design). this update notice request requires that users return these original design products to varian brachytherapy for replacement with the updated designs for them free of charge.

Device

SEGMENTED CYLINDER SET
  • Model / Serial
    Model Catalog: GM11004150 (Lot serial: >10 Serial numbers.); Model Catalog: GM11004150 (Lot serial: Contact manufacturer.)
  • Product Description
    SEGMENTED CYLINDER SET
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.