FDA Medical Device Recalls (openFDA)
NordicNeuroLab AS: 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.
- Recall number
- Z-2103-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-10-28
- Posted
- not on file
- Terminated
- 2021-03-31
- Reason
- Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
- 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
- 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
- Lot, serial or model codes
- HPS-2015-1.0-XXX HPS-2016-1.0-XXX
- 510(k) numbers
- ["K080515"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3006738448
- Firm city
- Bergen
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28