Class 2 Device Recall nordicneurolab

• Date Initiated by Firm: June 16, 2022
• Create Date: July 25, 2022
• Recall Status: Terminated on September 04, 2024
• Recall Number: Z-1462-2022
• Recall Event ID: 90480
• 510(K)Number: K133910
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: nordicBrainEX, software versions 2.21 through 2.3.10
• Code Information: UDI 07090042059015, software versions 2.21 through 2.3.10
• Recalling Firm/ Manufacturer: NordicNeuroLab AS; Mollendalsveien 65c; Bergen Norway
• For Additional Information Contact: +47 90 56 61 31
• Manufacturer Reason for Recall: When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
• FDA Determined Cause: Software design
• Action: The firm sent a notice regarding a Critical Bug in nordicBrainEx version 2.2.1 to 2.3.10 on 06/16/2022 by email. The notice explained the problem and advised users to use extra caution when viewing the exported results. A software revision will be released to correct the issue.
• Quantity in Commerce: 243 units
• Distribution: US Nationwide distribution.
• 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