NordicNeuroLab AS recalls fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner…

Recall date

August 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3023-2018

FDA classification

Class II

Brand / firm

NordicNeuroLab AS

Sold / distributed

worldwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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