Company: NordicNeuroLab AS
Date of Enforcement Report 6/6/2018
Class II:
PRODUCT
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Recall Number: Z-2044-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
NordicNeuroLab AS, Bergen Norway on 9/12/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
97 licenses
DISTRIBUTION
Nationwide and Internationally