Events

Alerta De Seguridad para Radiographic Image Table. Omega IV Used Angiographic Table / X-ray System: (1) Model 2120637, (2) Model 2154474, (3) Model 2219154, Model 4, Model 2219155, Model (6) Model 2252037

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Medical Systems; GE Medical Systems Europe.

¿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
  • ID del evento
    270
  • Fecha
    2002-01-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The cable that controls movement from the top of the table may break, causing a dislocation of movement. the distributor began corrective work on modifying the instructions distributed by ge medical systems engineers on may 1, 2001.
  • Acción
    Make sure you have been contacted by GE Medical Systems. Identify and isolate any affected product in your inventory. For more information, contact the GE Medical Systems Helpdesk in your city.

Device

Radiographic Image Table. Omega IV Used Angiographic Table / X-ray System: (1) Model 2120637, (2)...

Manufacturer

GE Medical Systems; GE Medical Systems Europe
  • Source
    ANVSANVISA