Recall Z-2120-2016

ZYTO Technologies, Inc. · initiated November 23, 2015

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / 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

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: Labeling False and Misleading

Action taken

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..

Details

Recall number
Z-2120-2016
Initiated
November 23, 2015
Terminated
December 21, 2017
Product code
GZO – Device, Galvanic Skin Response Measurement
Quantity
1252 total
Distribution
Nationwide. Canadian and other foreign consignees. No VA/govt/military.
Recalling firm
ZYTO Technologies, Inc., Lindon, UT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2121-2016 Class IIThe ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin…ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due… 11/23/2015Terminated