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.