Events

Rappel de Device Recall nordicICE v 2.3.14

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par NordicNeuroLab AS.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78467
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2061-2018
  • Date de mise en oeuvre de l'événement
    2015-07-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159628
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Version 2.3.14
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • Société-mère du fabricant (2017)
    Søre Øverli As
  • Source
    USFDA