Recall Z-2120-2016 ยท GZO Device, Galvanic Skin Response Measurement
ZYTO Technologies, Inc.
The ZYTO Tower is the input device to program the software with various virtual items.
| Date | Nov 23, 2015 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111308 | ZYTO HAND CRADLE Zyto Technologies, Inc., Aug 30, 2011 |