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
    153498
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-25
  • 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
    The instructions for use (ifu) sent with the product prior to 2004 indicates the allowed number of sterilization cycles is 100. the current version of the ifu indicates that the allowed number of sterilization is 25 and is the accurate limit for the flexible probe with a blocking washer gm11002420 usage.

Device

SEGMENTED CYLINDER SET
  • Model / Serial
    Model Catalog: GM11002420 (Lot serial: Y01 to E19)
  • Product Description
    Flexible Probe with Blocking Washer (part of the Segmented Cylinder Set)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.