# FDA recall Z-2042-2018

> **NordicNeuroLab AS** · Class II · device recall initiated 2014-12-15.

## Product

nordicTumorEx 1.0      nordicTumorEx 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the dia

## Reason for recall

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.

## Distribution

Worldwide Distribution - USA (nationwide) and to the countries of :  SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece

## Key facts

- **Recall number:** Z-2042-2018
- **Recalling firm:** NordicNeuroLab AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-12-15
- **Report date:** 2018-06-06
- **Termination date:** 2021-03-24

- **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-2042-2018

## Citation

> AI Analytics. FDA recall Z-2042-2018. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2042-2018. Source: US FDA. Licensed CC0.

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