Z-2120-2016Class II

The ZYTO Tower is the input device to program the software with various virtual items

Name: Z-2120-2016 The ZYTO Tower is the input device to program the software with various virtual items
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 Tower is the input device to program the software with various virtual items 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-2120-2016
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 Tower is the input device to program the software with various virtual items.
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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2120-2016
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)