Events

Recall of Device Recall IF 8000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zynex Medical, 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
    68447
  • Event Risk Class
    Class 2
  • Event Number
    Z-1874-2014
  • Event Initiated Date
    2009-01-25
  • Event Date Posted
    2014-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127719
  • 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
    Stimulator, muscle, powered - Product Code IPF
  • Reason
    Zynex notified customers that a malfunction in the if 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
  • Action
    Consignees were notified via letter on 6/25/2009. The letter identified the reason for the recall, and stated that customers could contact customer service at 1-866-940-7030 if they encountered any difficulties with the affected product. Otherwise, they could continue using the product as they have in the past.

Device

Device Recall IF 8000
  • Model / Serial
    Serial No: 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and 28813400.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. || Designed for use in physical therapy, rehabilitation, and pain relief applications.
  • Manufacturer
    Zynex Medical, Inc.

Manufacturer

Zynex Medical, Inc.
  • Manufacturer Address
    Zynex Medical, Inc., 9990 Park Meadows Dr, Lone Tree CO 80124-6739
  • Manufacturer Parent Company (2017)
    Zynex Inc.
  • Source
    USFDA