fMRI Hardware System — Class II medical device recall Z-2103-2018
Terminated recall by NordicNeuroLab AS, reported 2018-06-13, distributed nationwide. Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form th
| Recall number | Z-2103-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2017-10-28 |
| Classified | 2018-06-06 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2021-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, CH, CL, CN, FR, GB, IL, JP, KR, LT, NO, PL, RU, ZA |
| Quantity | 64 units |
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 for recall
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2103-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.