Recall Z-3023-2018— NordicNeuroLab AS
Class II · Terminated
Class II FDA medical device recall by NordicNeuroLab AS, initiated 2018-08-20, terminated 2020-09-16. It names one FDA 510(k) clearance: K092253. 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: Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner)..
- Recalling firm
- NordicNeuroLab AS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-20
- Terminated
- 2020-09-16
- Firm location
- Bergen, N/A, Norway
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.