BEUDAMED
    FDA Recall Terminated

    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

    Recall: Z-1874-2014 · Initiated January 25, 2009

    Recall

    Recall Number
    Z-1874-2014
    Event Number
    68447
    Firm
    Zynex Medical, Inc.
    FEI Number
    3000214920
    Product Code
    IPF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 25, 2009
    Posted
    June 26, 2014
    Terminated
    July 2, 2015
    Address
    9990 Park Meadows Dr, Lone Tree, CO, 80124-6739

    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.

    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.

    Distribution

    Nationwide Distribution

    Quantity

    1,461