Company:NordicNeuroLab AS
Date of Enforcement Report 6/6/2018
Class lI:
PRODUCT
nordicTumorEx 1.0nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images
Recall Number: Z-2042-2018
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 12/15/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16 licenses
DISTRIBUTION
Nationwide and Internationally
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