# FDA recall Z-2061-2018

> **NordicNeuroLab AS** · Class II · device recall initiated 2015-07-03.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2061-2018
- **Recalling firm:** NordicNeuroLab AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-07-03
- **Report date:** 2018-06-13
- **Termination date:** 2020-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bergen, N/A, Norway

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2061-2018

## Citation

> AI Analytics. FDA recall Z-2061-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2061-2018. Source: US FDA. Licensed CC0.

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