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Recall Observatory FDA recall evidence

Device 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).

Z-2121-2016

November 23, 2015

Class II

Product summary

Firm
ZYTO Technologies, Inc.
Event
Event 74273
Status
Terminated
Classification
Class II
Quantity
1252 total
Official record key
device-enforcement:Z-2121-2016

Official wording

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.

Code information: Not Applicable.

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

Derived failure modes

  • 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.