Home / Recalls / NordicNeuroLab AS / Z-2044-2018

Z-2044-2018 Class II Terminated

Recalled by NordicNeuroLab AS — Bergen, N/A

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
September 12, 2014
Termination Date
October 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
97 licenses

Product Description

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

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.

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.

Code Information

Version 2.3.14

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