Events

Alerta De Seguridad para Galeo

Según Health Ministry of Cuba, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Cuba que fue producido por BIOTRONIK, AG.

¿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
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 Cuba.
  • Notas adicionales en la data

Device

Galeo
  • Modelo / Serial
  • Descripción del producto
    Coronary Angioplasty Guide
  • 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
    HMC