Events

Retiro De Equipo (Recall) de Device Recall nordicBrainEX

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
    80162
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2045-2018
  • Fecha de inicio del evento
    2012-12-21
  • 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=164721
  • 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
    There is an error related to the relative geometry between fiber tracts in a fiber group and images. the error occurs in the following situations: a group of fibers has been selected using the voi functionality and put into a fiber group. this is done with images series a visualized in the 3d viewer. then a new images series b is visualized in the 3d viewer. if image series a and b have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking a to b will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on b in the 3d viewer. furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the mpr on b, the positioning will not be correct. the misalignment will be equal to the rotations/translations necessary to align a with b.
  • Acción
    The firm distributed the recall notification letter by email. The letter identified the affected product, problem and the actions to be taken. For questions contact NordicNeurolab Customer Service or if you would like to arrange a return customerservice@nordicneurolab.com.

Device

Device Recall nordicBrainEX
  • Modelo / Serial
    version 1.1.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
  • Descripción del producto
    nordicBrainEX || Product Usage: || nordicBrainEx 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.
  • 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