Z-2103-2018Class II

fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus...

Name: Z-2103-2018 fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus...
Creator: NordicNeuroLab AS
Published: 2017-10-28
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2017-10-28 / Terminated / root cause: design

FDA source

NordicNeuroLab AS began a recall of fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be... on 2017-10-28. FDA classified it as Class II and gives the reason as "Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2103-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-28
Posted: 2018-06-06
Terminated: 2021-03-31
Recalling firm: NordicNeuroLab AS
Product: fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1.
Quantity in commerce: 64 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria
Product codes and lots: HPS-2015-1.0-XXX HPS-2016-1.0-XXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2103-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-06

Product code LNH

K080515Class IIFmri Hardware SystemNordicneurolab / cleared 2008-05-16

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)