Class 2 Device Recall nordicBrainEx 2.0

• Date Initiated by Firm: September 17, 2014
• Create Date: June 01, 2018
• Recall Status: Terminated on March 24, 2021
• Recall Number: Z-2050-2018
• Recall Event ID: 78466
• 510(K)Number: K133910
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
• Code Information: version 2.1 and older
• Recalling Firm/ Manufacturer: NordicNeuroLab AS; Mollendalsveien 65c; Bergen Norway
• 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 by email on 09/17/2014.
• Quantity in Commerce: 22 licenses
• Distribution: USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
• 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