Events

Alerta De Seguridad para LASER LIGTH - DENTAL EQUIPMENT

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA.

¿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
    752
  • Fecha
    2003-10-30
  • 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
    considering paragraph 3 of art. 111 of the Internal Regulation approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the arts. 12 and 25 and 50 of Law no. 6,360, of September 23, 1976, c / c, arts. 14, 35 and 75 of Decree No. 79.094 of January 5, 1977, c / c RDC-185, of October 22, 2001; considering items I, IV, V, X and XXIX of art. 10, of Law no. No. 6,437, August 20, 1977; considering the decision rendered to fls. 40 in the case file 25351.014843 / 2003-95
  • Causa
    Do not have registration with anvisa, imposing health risk.
  • Acción
    Determine, as a measure of health interest, throughout Brazil, the prohibition of advertising and publicity, exposure to the sale and sale of the product LASER LIGTH, of KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA, located at Rua Gastão Vieira nº 471, Jardim Santa Felicia, São Carlos / SP, for not having registered with ANVISA, imposing health risk.

Device

LASER LIGTH - DENTAL EQUIPMENT

Manufacturer

KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA
  • Source
    ANVSANVISA