nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by traine...
FDA Device Recall #Z-2042-2018 - Class II, December 15, 2014
Recall Summary
| Recall Number | Z-2042-2018 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | NordicNeuroLab AS |
| Location | Bergen, N/A |
| Product Type | Devices |
| Quantity | 16 licenses |
Product Description
nordicTumorEx 1.0 nordicTumorEx 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
Reason for Recall
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
Lot / Code Information
Version 1.0.4
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-2050-2018 | Class II | nordicBrainEx 2.0 provides analysis and visuali... | Sep 17, 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.