FDA Medical Device Recalls (openFDA)
NordicNeuroLab AS: nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
- Recall number
- Z-2044-2018
- Recalling firm
- NordicNeuroLab AS
- Product
- nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
- Status
- Terminated
- Initiated
- 2014-09-12
- Posted
- not on file
- Terminated
- 2020-10-06
- 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.
- Root cause
- Software design
- 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 customerservice@nordicneurolab.com or 1-262-337-2909.
- Quantity
- 97 licenses
- 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.
- Lot, serial or model codes
- Version 2.3.14
- 510(k) numbers
- ["K082441"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006738448
- Firm city
- Bergen
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28