NordicNeuroLab AS: Medical Device Recall in 2018 - (Recall #: Z-2044-2018)

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:

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

Product Classification:

Class II

Date Initiated: September 12, 2014

Date Posted: June 6, 2018

Recall Number: Z-2044-2018

Event ID: 78463

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: 97 licenses

Code Information:

Version 2.3.14

Distribution Pattern:

Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.

Voluntary or Mandated:

Voluntary: Firm initiated