Events

Recall of THERADOME LASER HELMET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THERADOME 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
    34517
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-31
  • 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 theradome lh80 pro laser helmet a medical device is not licenced by health canada.

Device

THERADOME LASER HELMET
  • Model / Serial
    Model Catalog: LH80 PRO (Lot serial: >10 contact mfg)
  • Product Description
    Theradome LH80 Pro Laser Helmet
  • Manufacturer
    THERADOME INC.

Manufacturer

THERADOME INC.
  • Manufacturer Address
    PLEASANTON
  • Manufacturer Parent Company (2017)
    Theradome Inc.
  • Source
    HC