FDA Recall Terminated

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

Recall: Z-2044-2018 · Initiated September 12, 2014

Recall

Recall Number
Z-2044-2018
Event Number
78463
Firm
NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
FEI Number
3006738448
Product Code
LLZ
Status
Terminated
Root Cause
Software design
Initiated
September 12, 2014
Terminated
October 6, 2020

Description

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

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.

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.

Distribution

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

Quantity

97 licenses