FDA Medical Device Recalls (openFDA)
ZYTO Technologies, Inc.: The ZYTO Tower is the input device to program the software with various virtual items.
- Recall number
- Z-2120-2016
- Recalling firm
- ZYTO Technologies, Inc.
- Product
- The ZYTO Tower is the input device to program the software with various virtual items.
- Status
- Terminated
- Initiated
- 2015-11-23
- Posted
- not on file
- Terminated
- 2017-12-21
- Reason
- 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
- 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
- 1252 total
- Distribution
- Nationwide. Canadian and other foreign consignees. No VA/govt/military.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111308"]
- PMA numbers
- not on file
- Product code
- GZO
- Firm FEI
- 3008493238
- Firm city
- Lindon
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28