nordicICE v 2 — Class II medical device recall Z-2061-2018
Terminated recall by NordicNeuroLab AS, reported 2018-06-13, distributed nationwide. The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into accoun
| Recall number | Z-2061-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2015-07-03 |
| Classified | 2018-06-04 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CN, CZ, DE, DK, FR, GR, HU, IN, IT, JP, KW, MY, NL, NO, PL |
| Quantity | 121 licenses |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2061-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.