Events

Recall of VARISEED 8.0

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
    90283
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-03
  • 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
    Some variseed users have inadvertently entered a source activity in units of air kerma (u) when the actual source activity was specified in millicuries (mci). variseed requires the user to enter the activity of the source that will be implanted into the patient. the activity may be entered in "u" or "mci". when entering the activity in u the value is accepted and no further message is displayed. if the activity is entered as mci a message is shown indicating that variseed will show "u" in the user interface from that point on and notifying the user of the convered value in u. a data entry error of this nature should be obvious to the user. the variseed software system provides a message at the time data is entered that the user has to click to accept and move forward in planning. also both units of activity are shown on the variseed report headers.

Device

VARISEED 8.0
  • Model / Serial
    Model Catalog: 8.0 (Lot serial: Contact manufacturer.); Model Catalog: 8.0 (Lot serial: >10 serial numbers.)
  • Product Description
    Variseed 8.0 (Brachytherapy Treatment Planning System)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.