FDA Device recall Z-1462-2022
nordicBrainEX, software versions 2.21 through 2.3.10
- FDA Device
- Class II
- terminated
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of nordicBrainEX, software versions 2.21 through 2.3.10 by Nordicneurolab As, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1462-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-16 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nordicneurolab As |
| Distribution | US |
Product
nordicBrainEX, software versions 2.21 through 2.3.10
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.
Identifiers
| code_info | UDI 07090042059015, software versions 2.21 through 2.3.10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1462-2022%22
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