Events

Notificaciones De Seguridad De Campo acerca de Pulsavac Plus

Según Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Czechia que fue producido por Zimmer Surgical, Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1296
  • Fecha
    2017-10-19
  • País del evento
    Czechia
  • Fuente del evento
    MHSIDCCCDMIS
  • URL de la fuente del evento
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notas / Alertas
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Notas adicionales en la data

Device

Pulsavac Plus
  • Modelo / Serial
    Catalog Number: 00515042001 00515048201 00515047500 00515049500 00515047501 00515049501 00515042000, 00515042001
  • Descripción del producto
    Medical devices for single use
  • Manufacturer
    Zimmer Surgical, Inc

Manufacturer

Zimmer Surgical, Inc
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    MHSIDCCCDMIS