FDA recall Z-3023-2018

Product

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

Reason for recall

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

Distribution

worldwide

Key facts

Status

Terminated

Initiation date

2018-08-20

Report date

2018-09-19

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3023-2018