Events

Alerte De Sécurité sur PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1305
  • Date
    2103-10-16
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA