Recall Z-3023-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
NordicNeuroLab AS
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
| Date | Aug 20, 2018 |
| Status | Terminated |
| Reason | Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner). |
| Root cause | Labeling design |
| Action | The firm sent a letter explaining the issue by email to the consignees on 08/20/2018. The firm requested that the consignee check the stock without removing the device from the magnet. It is was not in the magnet room, safely quarantine the device, and respond to the recall notice. The firm also directed any consignee who further distributed the product to notify those entities and to contact NNL. NNL will follow-up with them directly. NNL will upgrade all existing models with a safer design of the LCD Power supply unit. |
| Quantity | 163 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM Nordicneurolab, Oct 8, 2009 |