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U.S. Department of Health and Human Services

Class 2 Device Recall Lifelines Neuro

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  Class 2 Device Recall Lifelines Neuro see related information
Date Initiated by Firm October 11, 2019
Create Date December 20, 2019
Recall Status1 Terminated 3 on November 16, 2020
Recall Number Z-0723-2020
Recall Event ID 84270
510(K)Number K170441  
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
Product ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Code Information UDI: 0 0856310 00636 8 Lot Code: J380208 Model Number: PL00010-60.00-60.00-60.00-60.00-G
Recalling Firm/
Manufacturer		 LIFELINES NEURO COMPANY
900 E Main St
Louisville KY 40206
Manufacturer Reason
for Recall		 Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
FDA Determined
Cause 2		 Component change control
Action On October 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by overnight mail to the consumer/user accounts with replacement cables stating: Please find enclosed six packages of orange Temporal EEG electrode cables for use with your Trackit M system to replace the incorrectly labelled orange Temporal EEG electrode cables. Please discontinue using the orange Temporal Electrode cables that were provided with your Trackit M kit at delivery. Please return all of the orange Temporal Electrode Cables originally provided with the kit to our attention in the postage-paid envelope enclosed herein to assist with our containment and correction of the issue. The incorrectly labelled electrodes to return to our attention are marked by packaging lot #J380188 and #J380208. Please see below for the packaging labels from the lots of electrodes to be replaced. We apologize for the issues and inconvenience caused by this correction. Lifelines Neuro is dedicated to our goal of providing the best client engagement in the industry, acting as a trusted partner to help improve patient care and safety, processes, research, operational efficiency, and financial performance. Should you have any questions or wish to discuss this, please do not hesitate to contact me directly at 812-946-0444.
Quantity in Commerce 12
Distribution US Nationwide distribution in the states of TX, TN, NC.
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 = GWQ and Original Applicant = MobileMedTek
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