Events

Alerta De Seguridad para Automatic histology slide dye applicator

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

¿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
    216
  • Fecha
    2000-12-01
  • 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 dispensers mentioned may leak through the air inlet on the cover, the interface of the cover and the cannon, or the nozzle. the manufacturer initiated a mail-order withdrawal sent on june 30, 2000. the company did not provide any information to ecri.
  • Acción
    Make sure you have received the correspondence sent on June 30, 2000 by Ventana Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with Ventana Medical Systems at 1 (520) 887-2155 in the United States.

Device

Automatic histology slide dye applicator

Manufacturer

Ventana Medical Systems Inc
  • Source
    ANVSANVISA