FDASeptember 17, 2014device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
nordicneurolab asnordicneurolab
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAnordicBrainEX, software versions 2.21 through 2.3.102022-06-16
- FDAfMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.12018-08-20
- FDAfMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through ...2017-10-28
- FDAnordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis ...2015-07-03
- FDAnordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analys...2014-12-15
- FDAnordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.2014-09-12
- FDAnordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing...2012-12-21
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →