NordicNeuroLab AS recalls nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical tech…

Recall date

September 12, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2044-2018

FDA classification

Class II

Brand / firm

NordicNeuroLab AS

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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