FDAAugust 20, 2018device

fMRI 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 1.1

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).

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 - 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
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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