Home / Recalls / ZYTO Technologies, Inc. / Z-2121-2016

Z-2121-2016 Class II Terminated

Recalled by ZYTO Technologies, Inc. — Lindon, UT

Recall Details

Product Type: Devices
Report Date: July 13, 2016
Initiation Date: November 23, 2015
Termination Date: December 21, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1252 total

Product 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 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.

Distribution Pattern

Nationwide. Canadian and other foreign consignees. No VA/govt/military.

Code Information

Not Applicable.