Summary
The FDA issued a Class II for nordicBrainEX, software versions 2.21 through 2.3.10 by NordicNeuroLab AS. Reason: When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe d.
Details
Source
Device Recall
External ID
Z-1462-2022
Action Date
2022-08-03
Status
Terminated
Category
device
Product Description
nordicBrainEX, software versions 2.21 through 2.3.10
Lot/Code Info: UDI 07090042059015, software versions 2.21 through 2.3.10
Quantity Affected: 243 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-16
Company
Bergen
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NordicNeuroLab AS has 6 FDA actions in our database, including 1 recall and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NordicNeuroLab AS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NordicNeuroLab AS have FDA actions?
NordicNeuroLab AS has 6 FDA actions in our database, including 1 recall and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1462-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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