FDAClass IIJune 13, 2018

nordicICE v 2.3.14 nordicICE is an image processing recall

nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and…

Why was nordicICE v 2.3.14 nordicICE is an image processing recalled?

The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Version 2.3.14

Product
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and…
Recalling firm
NordicNeuroLab AS
Quantity
121 licenses
Distribution
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
Recall date
June 13, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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