ZYTO Technologies, Inc. recalls The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from mos…

Recall date

November 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2121-2016

FDA classification

Class II

Brand / firm

ZYTO Technologies, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).