Events

Recall of TECHTRAINER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BTE TECHNOLOGIES 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
    93465
  • Event Risk Class
    III
  • Event Initiated Date
    2010-10-22
  • 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
    Sale of unlicensed class ii medical devices. the affected products were originally classified as by bte as class i medical devices. recentlythe devices were classified as class ii medical devices and appropriate class ii licensing was not in place and license numbers are not listed on product labels.

Device

TECHTRAINER
  • Model / Serial
    Model Catalog: (Lot serial: not applicable)
  • Product Description
    TechTrainer
  • Manufacturer
    BTE TECHNOLOGIES INC.

Manufacturer

BTE TECHNOLOGIES INC.
  • Manufacturer Address
    HANOVER
  • Manufacturer Parent Company (2017)
    BTE Technologies
  • Source
    HC