The ZYTO Tower is the input device to program the software with… — Class II medical device recall Z-2120-2016
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-2120-2016 |
|---|---|
| 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 |
| Serial numbers | 0114DPN00000-0114DPN00017, 0114TPN12332-0114TPN12347, 0114TPN12348-0114TPN12372, 0114TPN12373-0114TPN12393, 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, 1507TPN00001-1507TPN00002, 1507TPN00003-1507TPN00017 and 23 more |
Product
The ZYTO Tower is the input device to program the software with various virtual items.
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-2120-2016. 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.