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Terminated

The ZYTO Tower is the input device to program the software with various virtual items.

FDA Recall Z-2120-2016 · Posted None

Recalling FirmZYTO Technologies, Inc.
Recall StatusTerminated
Product CodeGZO
Date Initiated2015-11-23
Date Terminated2017-12-21
Product Quantity1252 total

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.

Firm 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..

Root Cause

Labeling False and Misleading

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111308ZYTO HAND CRADLEZyto Technologies, Inc. · 2011-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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