The Recall Desk

FDA (Devices) recall action 74273

ZYTO Technologies, Inc. recalled 2 products on 2016-07-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-07-13
Critical
0
Units
2,504

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-07-13

    ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations

    ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.

    Product
    The ZYTO Tower is the input device to program the software with various virtual items.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-07-13

    ZYTO Software Recalled for Exceeding 510(k) Clearance Claims

    ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.

    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).
    Category
    Distribution
    0 states