Events

Recall of Device Recall reVive Light Therapy Pain Relief Device

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

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
    73779
  • Event Risk Class
    Class 2
  • Event Number
    Z-1581-2016
  • Event Initiated Date
    2016-03-30
  • Event Date Posted
    2016-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144963
  • 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
    Lamp, infrared, therapeutic heating - Product Code ILY
  • 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.

Device

Device Recall reVive Light Therapy Pain Relief Device
  • Model / Serial
    Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 1 consignee located in the United States.
  • Product 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.
  • Manufacturer
    LED Technologies, LLC

Manufacturer

LED Technologies, LLC
  • Manufacturer Address
    LED Technologies, LLC, 6000 Greenwood Plaza Blvd, Ste 110, Greenwood Village CO 80111-4816
  • Source
    USFDA