Medical imaging software may flip left-right brain image orientation
NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The defect affects diagnostic accuracy in medical imaging software, creating a risk of harm through potential misinterpretation of critical diagnostic data, qualifying it as a risk-of-harm product without reported injury.
Plain-English summary
NordicNeuroLab AS is recalling nordicBrainEX medical imaging analysis software, versions 2.21 through 2.3.10, which has been distributed nationwide in the United States. Approximately 243 units are affected.
The software contains a defect that may flip the left and right sides of brain imaging data when exporting merged results from the BOLD, DSC, and DCE analysis modules. This defect occurs specifically when both the underlay and overlay images originated from multiframe datasets.
This recall was classified as a Class II medical device recall by the U.S. Food and Drug Administration. Healthcare providers and facilities using affected versions of nordicBrainEX should contact NordicNeuroLab AS for information about corrective actions.
The recalled product
- Product
- nordicBrainEX, software versions 2.21 through 2.3.10
- Manufacturer
- NordicNeuroLab AS
- Hazard
- image-orientation
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 07090042059015
- software versions 2.21 through 2.3.10
Distribution
Distributed nationwide across the United States.
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