Recall Z-2121-2016— ZYTO Technologies, Inc.

Name: FDA recall Z-2121-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-23

Class II · Terminated

Class II FDA medical device recall by ZYTO Technologies, Inc., initiated 2015-11-23, terminated 2017-12-21. It names one FDA 510(k) clearance: K111308. 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).. 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..

Recalling firm: ZYTO Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Terminated: 2017-12-21
Firm location: Lindon, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K111308 — ZYTO HAND CRADLEZyto Technologies, Inc.·cleared 2011-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.