FDADecember 15, 2014device
nordicTumorEx 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...
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
- FDAnordicBrainEx 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.2014-09-17
- 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
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