nordicBrainEX recall
nordicBrainEX, software versions 2.21 through 2.3.10
Why was nordicBrainEX 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 07090042059015, software versions 2.21 through 2.3.10
- Product
- nordicBrainEX, software versions 2.21 through 2.3.10
- Recalling firm
- NordicNeuroLab AS
- Quantity
- 243 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 3, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)