Class 2 Device Recall nordicTumorEx 1.0

• Date Initiated by Firm: December 15, 2014
• Create Date: May 31, 2018
• Recall Status: Terminated on March 24, 2021
• Recall Number: Z-2042-2018
• Recall Event ID: 78460
• 510(K)Number: K123306
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: 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.
• Code Information: Version 1.0.4
• Recalling Firm/ Manufacturer: NordicNeuroLab AS; Mollendalsveien 65c; Bergen Norway
• For Additional Information Contact: 262-337-2909
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: The firm notified their consignees of the software problem by email on December 14, 2014. For further questions please call (262) 337-2909.
• Quantity in Commerce: 16 licenses
• Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ