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U.S. Department of Health and Human Services

Class 2 Device Recall ZYTO Tower

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  Class 2 Device Recall ZYTO Tower 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-2120-2016
Recall Event ID 74273
510(K)Number K111308  
Product Classification Device, galvanic skin response measurement - Product Code GZO
Product The ZYTO Tower is the input device to program the software with various virtual items.
Code Information Serial Number  TI2001-TI2003  TI2021-TI2076  TI2081-TI2092  TI2095-TI2104  TI2105-TI2113  TI2114-TI2127  TI2128-TI2138  TI2139-TI2150  TI2151-TI2158  TI2159-TI2211  TI2212-TI2213  TI2214-TI2215  Tl2216  TI2217-TI2239  TI2240-TI2279  Tl2280-Tl2304  TI2305-TI2314  Tl2315-Tl2328  Tl2331  0114TPN12332-0114TPN12347  0114TPN12348-0114TPN12372  0114TPN12373-0114TPN12393  0114DPN00000-0114DPN00017  0114TPN12394-0114TPN12401  0114TPN12402-0114TPN12407  0114TPN12408-0114TPN12409  0114TPN12410-0114TPN12414  0114TPN12415-0114TPN12416  0115DPN00000-0115DPN00008  1501TPN00000-1501TPN00003  1501TPN00004-1501TPN00008  1501TPN00009-1501TPN00010  1501TPN00011-1501TPN00018  1501TPN00019-1501TPN00020  1502TPN00000-1502TPN00007  1503TPN00000-1503TPN00007  1503TPN00008-1503TPN00035  1503TPN00036-1503TPN00040  1505TPN00000-1505TPN00002  1505TPN00003-1505TPN00021  1506TPN00000-1506TPN00002  1506TPN00003-1506TPN00005  1507TPNOOOOO  1507TPN00001-1507TPN00002  1507TPN00003-1507TPN00017  1508TPN00000-1508TPN00004  1509TPN00000-1509TPN00009  1509TPN00010-1509TPN00019
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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