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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74273

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 23, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ZYTO Technologies, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-2120-2016
Recall number
Z-2120-2016
Initiated
November 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
ZYTO Technologies, Inc.
Quantity
1252 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Number TI2001-TI2003 TI2021-TI2076 TI2081-TI2092 TI2095-TI2104 TI2105-TI2113 TI2114-TI2127 TI2128-TI2138 TI2139-TI2150 TI2151-TI2158 TI2159-TI2211 TI2212-TI2213 TI2214-TI2215 Tl2216 TI2217-TI2239 TI2240-TI2279 Tl2280-Tl2304 TI2305-TI2314 Tl2315-Tl2328 Tl2331 0114TPN12332-0114TPN12347 0114TPN12348-0114TPN12372 0114TPN12373-0114TPN12393 0114DPN00000-0114DPN00017 0114TPN12394-0114TPN12401 0114TPN12402-0114TPN12407 0114TPN12408-0114TPN12409 0114TPN12410-0114TPN12414 0114TPN12415-0114TPN12416 0115DPN00000-0115DPN00008 1501TPN00000-1501TPN00003 1501TPN00004-1501TPN00008 1501TPN00009-1501TPN00010 1501TPN00011-1501TPN00018 1501TPN00019-1501TPN00020 1502TPN00000-1502TPN00007 1503TPN00000-1503TPN00007 1503TPN00008-1503TPN00035 1503TPN00036-1503TPN00040 1505TPN00000-1505TPN00002 1505TPN00003-1505TPN00021 1506TPN00000-1506TPN00002 1506TPN00003-1506TPN00005 1507TPNOOOOO 1507TPN00001-1507TPN00002 1507TPN00003-1507TPN00017 1508TPN00000-1508TPN00004 1509TPN00000-1509TPN00009 1509TPN00010-1509TPN00019

Distribution pattern

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

device · product 2 of 2

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).

Z-2121-2016
Recall number
Z-2121-2016
Initiated
November 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
ZYTO Technologies, Inc.
Quantity
1252 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Not Applicable.

Distribution pattern

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

Field note

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