FDA Medical Device Recalls (openFDA)
NordicNeuroLab AS: nordicBrainEX, software versions 2.21 through 2.3.10
- Recall number
- Z-1462-2022
- Recalling firm
- NordicNeuroLab AS
- Product
- nordicBrainEX, software versions 2.21 through 2.3.10
- Status
- Terminated
- Initiated
- 2022-06-16
- Posted
- not on file
- Terminated
- 2024-09-04
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 243 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI 07090042059015, software versions 2.21 through 2.3.10
- 510(k) numbers
- ["K133910"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006738448
- Firm city
- Bergen
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28