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NordicNeuroLab AS recalls nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical t
Recalled June 6, 2018 · FDA recall Z-2044-2018 · NordicNeuroLab AS
Hazard
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. · FDA Class II
Units
97 licenses
Sold at
Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
Description
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.
Product
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Manufacturer(s)
NordicNeuroLab AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →