Z-2121-2016Class II

The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response...

Name: Z-2121-2016 The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response...
Creator: ZYTO Technologies, Inc.
Published: 2015-11-23
License: https://open.fda.gov/license/

ZYTO Technologies, Inc. / initiated 2015-11-23 / Terminated / root cause: labeling and UDI

FDA source

ZYTO Technologies, Inc. began a recall of 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... on 2015-11-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2121-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2016-07-01
Terminated: 2017-12-21
Recalling firm: ZYTO Technologies, Inc.
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).
Product code: GZO Device, Galvanic Skin Response Measurement
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Not Applicable.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2121-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2120-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-01
Z-2121-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-01

Product code GZO

K111308Class IIZyto Hand CradleZyto Technologies, Inc. / cleared 2011-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)