nordicBrainEX, software versions 2.21 through 2.3.10 recallZ-1462-2022 · NordicNeuroLab AS · initiated Jun 16, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NordicNeuroLab AS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
FDA root cause category: Software design
What the company is doing
The firm sent a notice regarding a Critical Bug in nordicBrainEx version 2.2.1 to 2.3.10 on 06/16/2022 by email. The notice explained the problem and advised users to use extra caution when viewing the exported results. A software revision will be released to correct the issue.
Recall details
- Recall number
- Z-1462-2022
- Status
- Terminated
- Initiated by the company
- Jun 16, 2022
- Recalling firm
- NordicNeuroLab AS
- Quantity
- 243 units
- Product code
- LLZ
- FDA submissions
- K133910
- Distribution
- US Nationwide distribution.
Product description
nordicBrainEX, software versions 2.21 through 2.3.10
Code information (models, lots, serial numbers)
UDI 07090042059015, software versions 2.21 through 2.3.10
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- nordicBrainEx 2.3Nordicneurolab AS · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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