nordicTumorEx 1 — Class II medical device recall Z-2042-2018
Terminated recall by NordicNeuroLab AS, reported 2018-06-06, distributed nationwide. An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientat
| Recall number | Z-2042-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2014-12-15 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2021-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB, GR, JP, KR, NO, RU, SE |
| Quantity | 16 licenses |
| Reason classes | labeling |
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 diagnostic process.
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.
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-2042-2018. 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.