Events

Alerta De Seguridad para Controllers to Automate Autoclaves.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    699
  • Fecha
    2002-04-17
  • 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
    LAW No. 6.437 OF AUGUST 20, 1977 - (Published in the Official Gazette of 24 August 1977, page 11145) - Configures infractions to federal sanitary legislation, establishes the respective sanctions, and makes other provisions. Art. 10. Sanitary infractions: XVI - Change the manufacturing process of products subject to sanitary control, modify its basic components, name, and other elements subject to registration, without the necessary authorization from the competent sanitary body.
  • Causa
    Existence of companies in the market that automate autoclaves of any manufacturing, replacing the existing electromechanical controls, making the autoclave fully automatic without the necessary consent of the manufacturer and authorization of the competent sanitary body.
  • Acción
    Do not accept that companies automate the autoclaves, with controllers, without the necessary consent of the manufacturer and authorization of the competent sanitary organ. ANVISA is supervising these companies.

Device

Controllers to Automate Autoclaves.
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA