Events

Alerta De Seguridad para Angiography X-ray System: (1) LC +, (2) LCA, (3) LCA +, (4) LCLP +, (5) LCN +, (6) LCV +. Models Nos: 2120351, 2120351-2, 2219157, 2279157-2, 2251041, 2154096, 2219156, 2251039; all the. (internationally)

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
    368
  • Fecha
    2002-01-09
  • 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 c-arm of the above x-ray system can move quickly, forcing the collimator down the table. the distributor initiated a correction, modifying the instructions, by letter dated april 1, 2001, distributed to its service engineers.
  • Acción
    The distributor states that all US and Canadian units are being corrected and that most units internationally have already been corrected. If you have not been consulted for repair, or for more information, contact your local GE Medical Systems service provider. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Angiography X-ray System: (1) LC +, (2) LCA, (3) LCA +, (4) LCLP +, (5) LCN +, (6) LCV +. Models ...

Manufacturer

GE Medical Systems; GE Medical Systems Europe
  • Source
    ANVSANVISA