CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
nordicTumorEx 1.0 nordicTumorEx is an image processing recalled
NordicNeuroLab AS is recalling nordicTumorEx 1.0 nordicTumorEx is an image processing, distributed nationwide in the US. The recall was initiated on 15 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2042-2018
- FDA event ID
- 78460
- Recalling firm
- NordicNeuroLab AS, Bergen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2014
- FDA classified
- 31 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 15 Dec 2014 | Recall initiated by company | |
| 31 May 2018 | Classified by FDA | +1263 days |
| 6 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Version 1.0.4
Where was it sold?
Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from NordicNeuroLab AS
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|---|---|---|---|---|---|
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| Device | CLASS II | fMRI Hardware System VisualSystem allows video signals recalled | NordicNeuroLab AS | Other | N/A |
| Device | CLASS II | nordicICE v 2.3.14 nordicICE is an image processing recalled | NordicNeuroLab AS | Packaging Defects | Nationwide |
| Device | CLASS II | nordicBrainEx 2.0 provides analysis recalled by NordicNeuroLab AS | NordicNeuroLab AS | Other | N/A |
| Device | CLASS II | fMRI Hardware System - AudioSystem recalled by NordicNeuroLab AS | NordicNeuroLab AS | Other | Nationwide |
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