nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
FDA Recall Z-2044-2018 · Posted None
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Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-09-12
Date Terminated2020-10-06
Product Quantity97 licenses
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.
Firm Action
The firm notified their consignees by e-mail on 09/12/2014. Customers were informed of the reason for the recall, when the problem occurs, and what actions to take. Customers can perform a simple test by checking to see if there is a mismatch. Also, it is recommended that customers using BOLD and DTI, or other functionalities or workflows involving MPR switch to nordicBrainEx. Questions should be directed to NordicNeuroLab Customer Service at [email protected] or 1-262-337-2909.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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