BEUDAMED
    FDA Recall Terminated

    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

    Recall: Z-1581-2016 · Initiated March 30, 2016

    Recall

    Recall Number
    Z-1581-2016
    Event Number
    73779
    FEI Number
    3006315288
    Product Code
    ILY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 30, 2016
    Posted
    April 28, 2016
    Terminated
    November 30, 2016
    Address
    Blvd, LED Technologies, LLC 6000 Greenwood Plaza Ste 110, Greenwood Village, CO, 80111-4816

    Description

    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

    Reason

    Incorrect Power Supply in the package, rendering the device inoperable.

    Action

    Customers were notified on March 30, 2016 via telephone call. LED Technologies, Inc. provided the consignee with a letter to distribute to customers who purchased the reVive Light Therapy Pain Relief device, and included instructions to receive a replacement of the correct power supply.

    Distribution

    Distributed to 1 consignee located in the United States.

    Quantity

    32 units