Events

Alerta De Seguridad para PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5.

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
    1305
  • Fecha
    2103-10-16
  • 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
    Image management software is a health product that can be registered with Anvisa and falls under the same equipment risk class, according to the provisions of Resolution RDC 185/2001 and Technical Note 04/2012 / GQUIP / GGTPS / ANVISA . The products described in this alert are free softwares, available in the public domain, used for the visualization and management of results of exams and diagnoses (DICOM files) obtained in procedures of radiography, tomography, magnetic resonance, among others. Since they have not been evaluated by the Agency in the pre-marketing stage, there is no guarantee as to the safety and efficacy of these products. In addition, there is no information available on representatives / distributors / technical assistance related to products in Brazil, which is an additional risk factor for their use. To consult the Technical Note n ° 04/2012 / GQUIP / GGTPS / ANVISA go to: http://portal.anvisa.gov.br/wps/wcm/connect/f96009004a70f3abb6f1f64600696f00/Note+T%C3%A9cnica+04_2012_GQUIP+Software+ MODULE = AJPERES #### Update of Field Action on 05/01/2018, currently the product PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5 Is duly registered with Anvisa.
  • Causa
    The commercialization of software for the management and visualization of medical images not registered in anvisa is a sanitary infraction and its use by the health services represents a risk to the health of the population.
  • Acción
    Anvisa's Technovigilance Unit warns of the use of PACS image management software without registration in Anvisa, which is in disagreement with the legislation in force in Brazil.

Device

PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm...
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA