Events

Recall of ITT LIGHTGUIDES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DORNIER MEDIZINTECHNIK GMBH.

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
    140947
  • Event Risk Class
    II
  • 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
    Checking the high therapeutic laser power coming out of the lightguide in air might cause damage to the fiber tip due to missing heat dissipation.

Device

ITT LIGHTGUIDES
  • Model / Serial
    Model Catalog: (Lot serial: DEV LIC 7556)
  • Product Description
    DORNIER DIFFUSOR TIP LIGHTGUIDE
  • Manufacturer
    DORNIER MEDIZINTECHNIK GMBH

Manufacturer

DORNIER MEDIZINTECHNIK GMBH
  • Manufacturer Address
    GERMERING
  • Source
    HC