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U.S. Department of Health and Human Services

Class 2 Device Recall ZYTO Select Software and ZYTO Elite Software

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  Class 2 Device Recall ZYTO Select Software and ZYTO Elite Software see related information
Date Initiated by Firm November 23, 2015
Create Date July 01, 2016
Recall Status1 Terminated 3 on December 21, 2017
Recall Number Z-2121-2016
Recall Event ID 74273
510(K)Number K111308  
Product Classification Device, galvanic skin response measurement - Product Code GZO
Product The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
Code Information Not Applicable.
Recalling Firm/
Manufacturer		 ZYTO Technologies, Inc.
387 S 520 W Ste 200
Lindon UT 84042-1961
For Additional Information Contact
801-224-7199
Manufacturer Reason
for Recall		 ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Consignees were notified on 11/23/2015 via letter and email of an update to the ZYTO Select and Elite Software that would disable all tower functionality..
Quantity in Commerce 1252 total
Distribution Nationwide. Canadian and other foreign consignees. No VA/govt/military.
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 = GZO and Original Applicant = ZYTO TECHNOLOGIES, INC
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