Events

Recall of VAGINAL-APPLICATOR 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
    18354
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-29
  • 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 previous recall (hc# 55250) this addressed the flexible applicator probes that can shrink by up to 2mm after autoclaving. it has been determined that a portion of the shipped inventory of flexible applicator probes was not heat annealed. this recall supplements previous instructions by requring users to stop using any flexible applicator probes that may still be in inventory with lot numbers d01 to h14 inclusive. these applicator probes are to be returned to varian brachytherapy for replacement with lots after h14.

Device

VAGINAL-APPLICATOR SET
  • Model / Serial
    Model Catalog: GM11002560 (Lot serial: Contact manufacturer.); Model Catalog: GM11002560 (Lot serial: >10 lot numbers.); Model Catalog: GM11002560 (Lot serial: )
  • Product Description
    VAGINAL-APPLICATOR SET
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.