Events

Safety Alert for ECHOPULSE

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Theraclion.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-06-06
  • Event Date Posted
    2016-06-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160606.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: theraclion echopulse medical device manufacturer, theraclion, has issued a medical device safety alert concerning its echopulse [model number: thc800154-e]. the manufacturer has identified the necessity to improve the instructions for use of echopulse device and the clinician training. the aim of the added information is to: increase the user awareness on the recurrent laryngeal nerve (rln) most probable position. recommend to the final user to identify the area on the touch screen during the treatment in which the rln is and to include it in the "safety margin zone". this zone will automatically exclude the delivery of energy in that area. according to the manufacturer, they modify instructions for use and deliver the complementary training on the "safety margin zone" identification. the manufacturer also instructs end users to avoid treating next to the rln most probable position. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 june 2016.

Device

ECHOPULSE
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Theraclion ECHOPULSE
  • Manufacturer
    Theraclion

Manufacturer

Theraclion