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U.S. Department of Health and Human Services

Class 2 Device Recall microTargeting Guideline 4000" 5.0 System

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 Class 2 Device Recall microTargeting Guideline 4000" 5.0 Systemsee related information
Date Initiated by FirmJune 17, 2020
Create DateJuly 08, 2020
Recall Status1 Terminated 3 on November 02, 2020
Recall NumberZ-2540-2020
Recall Event ID 85897
510(K)NumberK183123 
Product Classification Electrode, depth - Product Code GZL
ProductFHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
Code Information Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
Recalling Firm/
Manufacturer		 FHC, Inc.
1201 Main St
Bowdoin ME 04287-7302
For Additional Information ContactSAME
207-666-5651
Manufacturer Reason
for Recall		An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
FDA Determined
Cause 2		Component change control
ActionFHC issued Urgent Medical Device Recall letter dated 6/17/20 via USPS certified return receipt,stating reason for recall, health risk and action to take: FHC, Inc. field representatives will be contacting you to return the effected product and issue a replacement. In the interim, we advise you to stop use of this product. Should you have any further questions regarding this matter you may contact me, by email at kmoeykens@fh-co.com or by telephone at 207-666-5425.
Quantity in Commerce6 units
DistributionUS Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GZL
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