Events

Alerta De Seguridad para EASY VISION COMPUTERIZED TOMOGRAPHY / MAGNETIC RESONANCE EQUIPMENT WITH 1X AND 2X VERSION SOFTWARE (EASY VISION COMPUTER TOMOGRAPHY / MAGNETIC RESONANCE WORKSTATIONS WITH SOFTWARE RELEASE 1.X AND 2.X)

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
    105
  • Fecha
    2001-08-03
  • 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
    If computerized tomographies are executed in different dates with the above systems, the set of images are found as a single examination. the distributor started a correction to field change in february 2001.
  • Acción
    MAKE SURE THAT YOUR SYSTEM HAS BEEN MODIFIED BY PHILIPS MEDICAL SYSTEMS NORTH AMERICA. IF YOUR SYSTEM HAS NOT ALREADY BEEN MODIFIED, OR FOR FURTHER INFORMATION, PLEASE CONTACT YOUR PHILIPS MEDICAL SYSTEMS REPRESENTATIVE. IN NORTH AMERICA, CALL BY PHONE 1 (800) 455-4350

Device

EASY VISION COMPUTERIZED TOMOGRAPHY / MAGNETIC RESONANCE EQUIPMENT WITH 1X AND 2X VERSION SOFTWAR...

Manufacturer

PHILIPS MEDICAL SYSTEMS NORTH AMERICA
  • Source
    ANVSANVISA