Events

Alerte De Sécurité sur ECHOPULSE

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Theraclion.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-06-06
  • Date de publication de l'événement
    2016-06-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160606.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Theraclion ECHOPULSE
  • Manufacturer
    Theraclion

Manufacturer

Theraclion