FDA Medical Device Recalls (openFDA)
ZYTO Technologies, Inc.: 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).
- Recall number
- Z-2121-2016
- 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).
- 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
- Not Applicable.
- 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