NordicNeuroLab AS: Medical Device Recall in 2018 - (Recall #: Z-2050-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 17, 2014

Date Posted: June 13, 2018

Recall Number: Z-2050-2018

Event ID: 78466

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.

Status: Terminated

Product Quantity: 22 licenses

Code Information:

version 2.1 and older

Distribution Pattern:

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated