FDA recall Z-2050-2018

Product

nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

Reason for recall

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Distribution

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

Key facts

Status

Terminated

Initiation date

2014-09-17

Report date

2018-06-13

Termination date

2021-03-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2018