FDA-Device2018-09-19Class II
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
NordicNeuroLab AS
Hazard
Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
Sold states
worldwide
Affected count
163 units
Manufactured in
Mollendalsveien 65c, N/A, Bergen, N/A, Norway
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3023-2018Don't want to check this manually?
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