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Recall Observatory FDA recall evidence

Device 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

Z-3023-2018

August 20, 2018

Class II

Product summary

Firm
NordicNeuroLab AS
Event
Event 80529
Status
Terminated
Classification
Class II
Quantity
163 units
Official record key
device-enforcement:Z-3023-2018

Official wording

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

Code information: Serial numbers: LPS-2011-1.0-XXX LPS-2012-1.0-XXX LPS-2012-1.1-XXX LPS-2013-1.1-XXX

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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