nordicBrainEX, software versions 2.21 through 2.3.10
Reported: August 3, 2022 Initiated: June 16, 2022 #Z-1462-2022
Product Description
nordicBrainEX, software versions 2.21 through 2.3.10
Reason for Recall
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.
Details
- Recalling Firm
- NordicNeuroLab AS
- Units Affected
- 243 units
- Distribution
- US Nationwide distribution.
- Location
- Bergen
Frequently Asked Questions
What product was recalled? ▼
nordicBrainEX, software versions 2.21 through 2.3.10. Recalled by NordicNeuroLab AS. Units affected: 243 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1462-2022.
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