FDA Device recall Z-2103-2018
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scan…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scan… by Nordicneurolab As, citing report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2103-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-28 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nordicneurolab As |
| Distribution | US |
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.
Reason
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Identifiers
| code_info | HPS-2015-1.0-XXX HPS-2016-1.0-XXX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2103-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.