Events

Recall of Device Recall ZYTO Select Software and ZYTO Elite Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ZYTO Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74273
  • Event Risk Class
    Class 2
  • Event Number
    Z-2121-2016
  • Event Initiated Date
    2015-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147046
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, galvanic skin response measurement - Product Code GZO
  • 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.
  • 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..

Device

Device Recall ZYTO Select Software and ZYTO Elite Software
  • Model / Serial
    Not Applicable.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Canadian and other foreign consignees. No VA/govt/military.
  • Product Description
    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).
  • Manufacturer
    ZYTO Technologies, Inc.

Manufacturer

ZYTO Technologies, Inc.
  • Manufacturer Address
    ZYTO Technologies, Inc., 387 S 520 W Ste 200, Lindon UT 84042-1961
  • Source
    USFDA