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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GZO
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