Events

Retiro De Equipo (Recall) de Device Recall nordicICE v 2.3.14

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por NordicNeuroLab AS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78467
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2061-2018
  • Fecha de inicio del evento
    2015-07-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159628
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, image processing, radiological - Product Code LLZ
  • Causa
    The bug causes bold activation maps to be visualized as overlays without taking the coregistration into account. any output created from these activation maps as overlays will not be adjusted according to the coregistration.
  • Acción
    The firm notified their customers by email on July 3, 2015. Actions to be taken by the customer/User: We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below. For further questions, please call (262) 337-2909.

Device

Device Recall nordicICE v 2.3.14
  • Modelo / Serial
    Version 2.3.14
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
  • Descripción del producto
    nordicICE v 2.3.14 || nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

NordicNeuroLab AS
  • Dirección del fabricante
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • Empresa matriz del fabricante (2017)
    Søre Øverli As
  • Source
    USFDA