Events

Alerta De Seguridad para MULTIDIAGNOST IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS FLUOROSCOPIC X-RAY SYSTEMS: (1) MODEL 3, (2) MODEL 4. ALL SYSTEMS OF THESE CITED MODELS INSTALLED BEFORE MARCH 2000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PHILIPS MEDICAL SYSTEMS NORTH AMERICA.

¿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
    107
  • Fecha
    2000-10-20
  • 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 ankle clamp in the above systems can release the foot of the plate and make the x-ray table diminish. the distributor started a correction by notifying service representatives on october 20, 2000.
  • Acción
    MAKE SURE THAT YOUR SYSTEM HAS BEEN MODIFIED BY PHILIPS MEDICAL SYSTEMS NORTH AMERICA. IF YOUR SYSTEM HAS NOT BEEN MODIFIED, OR FOR FURTHER INFORMATION, PLEASE CONTACT YOUR PHILIPS MEDICAL SYSTEMS NORTH AMERICA REPRESENTATIVE.

Device

MULTIDIAGNOST IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS FLUOROSCOPIC X-RAY SYSTEMS: (1) MODEL ...

Manufacturer

PHILIPS MEDICAL SYSTEMS NORTH AMERICA
  • Source
    ANVSANVISA