Z-3023-2018Class II

fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the...

Name: Z-3023-2018 fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the...
Creator: NordicNeuroLab AS
Published: 2018-08-20
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2018-08-20 / Terminated / root cause: labeling and UDI

FDA source

NordicNeuroLab AS began a recall of fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of... on 2018-08-20. FDA classified it as Class II and gives the reason as "Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3023-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-20
Posted: 2018-09-11
Terminated: 2020-09-16
Recalling firm: NordicNeuroLab AS
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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).
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm sent a letter explaining the issue by email to the consignees on 08/20/2018. The firm requested that the consignee check the stock without removing the device from the magnet. It is was not in the magnet room, safely quarantine the device, and respond to the recall notice. The firm also directed any consignee who further distributed the product to notify those entities and to contact NNL. NNL will follow-up with them directly. NNL will upgrade all existing models with a safer design of the LCD Power supply unit.
Quantity in commerce: 163 units
Distribution: worldwide
Product codes and lots: Serial numbers: LPS-2011-1.0-XXX LPS-2012-1.0-XXX LPS-2012-1.1-XXX LPS-2013-1.1-XXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3023-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3023-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-11

Product code LNH

K092253Class IIModification to Fmri Hardware SystemNordicneurolab / cleared 2009-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)