Important Safety Alerts

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