Events

Recall of NORDICICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NORDICNEUROLAB AS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25786
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Development team during the testing of new version (research) discovered a bug concerning handling of co-registration for bold series. the bug was verified in the current version of 2.3.14.

Device

NORDICICE
  • Model / Serial
    Model Catalog: VERSION 2.3 (Lot serial: All lots.)
  • Product Description
    NORDICICE
  • Manufacturer
    NORDICNEUROLAB AS

Manufacturer

NORDICNEUROLAB AS
  • Manufacturer Address
    BERGEN
  • Manufacturer Parent Company (2017)
    Søre Øverli As
  • Source
    HC