FDA Recall
Terminated
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: Z-2121-2016
·
Initiated November 23, 2015
Recall
- Recall Number
- Z-2121-2016
- Event Number
- 74273
- Firm
- ZYTO Technologies, Inc.
- FEI Number
- 3008493238
- Product Code
- GZO
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- November 23, 2015
- Terminated
- December 21, 2017
- Address
- 387 S 520 W, Ste 200, Lindon, UT, 84042-1961
Description
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
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.
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..
Distribution
Nationwide. Canadian and other foreign consignees. No VA/govt/military.
Quantity
1252 total