FDA recall Z-1462-2022

Product

nordicBrainEX, software versions 2.21 through 2.3.10

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.

Key facts

Status

Terminated

Initiation date

2022-06-16

Report date

2022-08-03

Termination date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2022