Events

Recall of HEAD AND NECK CT LOCALIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRA BURLINGTON MA 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
    102769
  • Event Risk Class
    II
  • Event Initiated Date
    2004-05-28
  • 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
    Printed overlay sheets used with hml-b do not have correct positions for the alignment crosshairs resulting in large discrepancies between the targeted position and actual isocentre position.

Device

HEAD AND NECK CT LOCALIZER
  • Model / Serial
    Model Catalog: HNLBSYS (Lot serial: 032580047); Model Catalog: HNLBSYS (Lot serial: 0412400023)
  • Product Description
    head and neck localiser version B
  • Manufacturer
    INTEGRA BURLINGTON MA INC.

Manufacturer

INTEGRA BURLINGTON MA INC.