Notificaciones De Seguridad De Campo acerca de Maestro Cardiac Ablation System

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 Czech Republic que fue producido por Boston Scientific Corporation.

¿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
    1604
  • Fecha
    2018-06-25
  • País del evento
  • Fuente del evento
    MHSIDCCCDMIS
  • URL de la fuente del evento
  • 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

  • Modelo / Serial
    Model Number: Maestro 4000 Footswitch: M004218500- Maestro 4000 Footswitch M00421850D0- Maestro 4000 Footswitch, Demo M00421850H0- Maestro 4000 Footswitch, Hospital Owned M00421850R0- Maestro 4000 Footswitch, Repaired M00421850Z0- Maestro 4000 Footswitch, Zero Cost Maestro Pump to Generator Cable: M004315000- Cable OI Pump to OI Maestro Maestro 4000 Controller: M00440000- Maestro 4000 Controller M0044000D0- Maestro 4000 Controller, Demo M0044000H0- Maestro 4000 Controller, Hospital Owned M0044000R0- Maestro 4000 Controller, Repaired M0044000Z0- Maestro 4000 Controller, Zero Cost
  • Descripción del producto
    Electromechanical medical devices
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS