Recall Z-2121-2016 ยท GZO Device, Galvanic Skin Response Measurement
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).
| 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 |