Drug recall
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded…
FDA recall event 80529 · Class II · NordicNeuroLab AS
Key facts
| Event ID | 80529 |
|---|---|
| Recall numbers | Z-3023-2018 |
| Recalling firm | NordicNeuroLab AS |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | Aug 20, 2018 |
| Report date | Sep 19, 2018 |
| Termination date | Sep 16, 2020 |
| City | Bergen |
| Country | Norway |
| FEI number | 3006738448 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: