Events

Notificaciones De Seguridad De Campo acerca de Ceiling pendant SPR 10

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por MZ Liberec a.s..

¿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
  • Fecha
    2015-05-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Following notification of an incident of failure of an axial segment of a ceiling pendant component, mz liberec is initiating a field safety corrective action. our company will substitute all the axial segments in the field for the new ones. you should receive these new parts along with this notice. we have also increased the inspections of these components as part of the manufacturing process to prevent reoccurrence of similar incidents in the future. it is important that all users inspect the axial segment components for excessive wear. if the any part of the segment has a thickness of less than 1.7 mm, users should cease using the product immediately.

Device

Ceiling pendant SPR 10

Manufacturer

MZ Liberec a.s.