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.
FDA Recall Z-2061-2018 · Posted None
Advertisement
Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-07-03
Date Terminated2020-09-16
Product Quantity121 licenses
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement