Events

Retiro De Equipo (Recall) de Nitinol

Según Health Andorra, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Andorra que fue producido por BIOTRONIK AG.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    ARS/2018/13868
  • Fecha
    2018-04-05
  • País del evento
    Andorra
  • Fuente del evento
    HA
  • URL de la fuente del evento
    https://www.salut.ad/alertes/alertes.php?_pagi_pg=13&data1=&data2=&tipus=PRODUCTES%20SANITARIS%20-%20Retirada&titol=
  • Notas / Alertas
    Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
  • Notas adicionales en la data

Device

Nitinol
  • Modelo / Serial
  • Descripción del producto
    Alert system of endoprosthesis, biotronik
  • Manufacturer
    BIOTRONIK AG

Manufacturer

BIOTRONIK AG
  • Empresa matriz del fabricante (2017)
    Ms Holding Ii Se
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HA