FDA Device recall Z-2061-2018
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physi…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physi… by Nordicneurolab As, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2061-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-03 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nordicneurolab As |
| Distribution | US |
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 medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
Reason
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.
Identifiers
| code_info | Version 2.3.14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2061-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.