nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used...

FDA Device Recall #Z-2045-2018 - Class II, December 21, 2012

Recall Summary

Recall Number Z-2045-2018
Classification Class II - Moderate risk
Date Initiated December 21, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm NordicNeuroLab AS
Location Bergen, N/A
Product Type Devices
Quantity 36 licenses

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan

Lot / Code Information

version 1.1.2

Other Recalls from NordicNeuroLab AS

Recall # Classification Product Date
Z-1462-2022 Class II nordicBrainEX, software versions 2.21 through 2... Jun 16, 2022
Z-3023-2018 Class II fMRI Hardware System VisualSystem allows vide... Aug 20, 2018
Z-2103-2018 Class II fMRI Hardware System - AudioSystem, Version 1.0... Oct 28, 2017
Z-2061-2018 Class II nordicICE v 2.3.14 nordicICE is an image pro... Jul 3, 2015
Z-2042-2018 Class II nordicTumorEx 1.0 nordicTumorEx is an imag... Dec 15, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.