Recall Z-2061-2018— NordicNeuroLab AS

Name: FDA recall Z-2061-2018
Creator: U.S. Food and Drug Administration
Published: 2015-07-03

Class II · Terminated

Class II FDA medical device recall by NordicNeuroLab AS, initiated 2015-07-03, terminated 2020-09-16. It names one FDA 510(k) clearance: K082441. Product: 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.. Reason: 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..

Recalling firm: NordicNeuroLab AS
Classification: Class II
Status: Terminated
Initiated: 2015-07-03
Terminated: 2020-09-16
Firm location: Bergen, N/A, Norway

510(k) clearances named in this recall

1 on FDA's record

K082441 — NORDICICE SOFTWARENordicimaginglab AS·cleared 2008-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.