Recall Z-2121-2016
ZYTO Technologies, Inc. · initiated November 23, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Not Applicable.
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.
FDA-determined cause: Labeling False and Misleading
Action taken
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..
Details
- Recall number
- Z-2121-2016
- Initiated
- November 23, 2015
- Terminated
- December 21, 2017
- Product code
- GZO – Device, Galvanic Skin Response Measurement
- Quantity
- 1252 total
- Distribution
- Nationwide. Canadian and other foreign consignees. No VA/govt/military.
- Recalling firm
- ZYTO Technologies, Inc., Lindon, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2120-2016 Class II | The ZYTO Tower is the input device to program the software with various virtual items.ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due… | 11/23/2015Terminated |