Events

Alerta De Seguridad para ECHOPULSE

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Theraclion.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-06-06
  • Fecha de publicación del evento
    2016-06-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160606.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Theraclion ECHOPULSE
  • Manufacturer
    Theraclion

Manufacturer

Theraclion