Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 6, 2018
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 dataset
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-p…
NordicNeuroLab As recalled nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used b… - a moderate-severity action.
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used b… was recalled by NordicNeuroLab As in June 6, 2018. Reason: An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orienta…. Check the official notice for the remedy. Verify recall #Z-2042-2018 with the FDA Devices before acting.
The recall
NordicNeuroLab As issued this moderate-severity FDA Devices recall-An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orienta….
- Moderate
- severity level
- Class II
- classification
- June 6, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2042-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2042-2018) was formally reported on June 6, 2018, with the manufacturer initiating the action on December 15, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. NordicNeuroLab As is listed as the recalling firm, operating out of Bergen, N/A. Federal records list the affected scope as 16 licenses.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
16 licenses
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2042-2018 |
| Date reported | June 6, 2018 |
| Date initiated | December 15, 2014 |
| Recalling firm | NordicNeuroLab As |
| Firm location | Bergen, N/A |
| Affected scope | 16 licenses |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2042-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by NordicNeuroLab As. Units affected: 16 licenses.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-2042-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2042-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 6, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.