fMRI Hardware System VisualSystem allows video signals from the… — Class II medical device recall Z-3023-2018
Terminated recall by NordicNeuroLab AS, reported 2018-09-19. Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR
| Recall number | Z-3023-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2018-08-20 |
| Classified | 2018-09-11 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-09-16 |
| Quantity | 163 units |
| Serial numbers | LPS-2011-1.0-XXX, LPS-2012-1.0-XXX, LPS-2012-1.1-XXX, LPS-2013-1.1-XXX |
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
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).
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-3023-2018. 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.