Events

Safety Alert for PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1305
  • Date
    2103-10-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA