The Recall Desk

Manufacturer

ZYTO Technologies, Inc.

2 recalls in our database name ZYTO Technologies, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-07-13

Of the 2 recalls from ZYTO Technologies, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-2121-2016·2016-07-13

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2016·2016-07-13

    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
    Medical Device
    Distribution
    Distributed nationwide