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Terminated

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

FDA Recall Z-3023-2018 · Posted None

Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-08-20
Date Terminated2020-09-16
Product Quantity163 units

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).

Firm 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.

Root Cause

Labeling design

Distribution Pattern

worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092253MODIFICATION TO FMRI HARDWARE SYSTEMNordicneurolab · 2009-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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