Recall Z-1462-2022 ยท LLZ System, Image Processing, Radiological
NordicNeuroLab AS
nordicBrainEX, software versions 2.21 through 2.3.10
| Date | Jun 16, 2022 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133910 | NORDICBRAINEX Nordicneurolab, Apr 4, 2014 |