Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 6, 2018
nordicBrainEX Product Usage: nordicBrainEx 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.
There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been se…
NordicNeuroLab As recalled nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to… - a moderate-severity action.
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to… was recalled by NordicNeuroLab As in June 6, 2018. Reason: There is an error related to the relative geometry between fiber tracts in a fiber group and images. The e…. Check the official notice for the remedy. Verify recall #Z-2045-2018 with the FDA Devices before acting.
The recall
NordicNeuroLab As issued this moderate-severity FDA Devices recall-There is an error related to the relative geometry between fiber tracts in a fiber group and images. The e….
- Moderate
- severity level
- Class II
- classification
- June 6, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2045-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2045-2018) was formally reported on June 6, 2018, with the manufacturer initiating the action on December 21, 2012. 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 36 licenses.
The documented reason for this recall is: There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and p… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan. 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
36 licenses
Related Recalls
6
3 from same agency
Product description
nordicBrainEX Product Usage: nordicBrainEx 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.
Reason for recall
There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2045-2018 |
| Date reported | June 6, 2018 |
| Date initiated | December 21, 2012 |
| Recalling firm | NordicNeuroLab As |
| Firm location | Bergen, N/A |
| Affected scope | 36 licenses |
| Distribution | Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan |
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-2045-2018) 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? ▼
nordicBrainEX Product Usage: nordicBrainEx 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.. Recalled by NordicNeuroLab As. Units affected: 36 licenses.
Why was this product recalled? ▼
There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-2045-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2045-2018) 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.