The ZYTO Select and ZYTO Elite software programs are used to rank… — Class II medical device recall Z-2121-2016
Terminated recall by ZYTO Technologies, Inc., reported 2016-07-13, distributed nationwide. ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due t
| Recall number | Z-2121-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZYTO Technologies, Inc., Lindon, UT, United States |
| Recall initiated | 2015-11-23 |
| Classified | 2016-07-01 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,252 total |
| Reason classes | software |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2121-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.