Reported Sep 19, 2018 · Terminated

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

NordicNeuroLab AS

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NordicNeuroLab AS · Mollendalsveien 65c · Bergen, N/A · N/A

Is this the product you have?

  • 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
Lot codes and dates
  • Serial numbersLPS-2011-1.0-XXX LPS-2012-1.0-XXX LPS-2012-1.1-XXX LPS-2013-1.1-XXX
Amount recalled
163 units

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).

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2020 · Data as of Sep 19, 4:48 PM UTC

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