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U.S. Department of Health and Human Services

Class 2 Device Recall fMRI Hardware System VisualSystem

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  Class 2 Device Recall fMRI Hardware System VisualSystem see related information
Date Initiated by Firm August 20, 2018
Create Date September 11, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-3023-2018
Recall Event ID 80529
510(K)Number K092253  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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
Code Information Serial numbers:  LPS-2011-1.0-XXX  LPS-2012-1.0-XXX  LPS-2012-1.1-XXX  LPS-2013-1.1-XXX
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
Manufacturer 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).
FDA Determined
Cause 2		 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 in Commerce 163 units
Distribution worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = NORDICNEUROLAB
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