NordicNeuroLab Recalls fMRI LCD Monitor Power Supplies Due to Magnet Bore Risk
NordicNeuroLab AS is recalling 163 LCD monitor power supplies for fMRI systems because they were reported to be dragged into the magnet bore.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (ferromagnetic object in MRI) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
NordicNeuroLab AS is recalling 163 units of the LCD Monitor Power supply (LPS) for the VisualSystem fMRI Hardware System. The affected units are Versions 1.0 and 1.1, with serial numbers beginning with LPS-2011-1.0, LPS-2012-1.0, LPS-2012-1.1, or LPS-2013-1.1. These products were distributed worldwide.
The recall was initiated due to complaints that the power supply units were being dragged into the magnet bore of the MR Scanner. This hazard presents a risk of damage to the equipment and potential safety issues within the MRI environment.
Users of these devices should stop using the affected power supplies immediately and contact NordicNeuroLab AS for instructions on how to proceed with the recall.
The recalled product
- 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
- Manufacturer
- NordicNeuroLab AS
- Category
- Medical Device — fMRI Hardware
- Affected units
- 163
Distribution
Distribution scope not specified by the agency.
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