Z-1581-2016Class II

reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS)

Name: Z-1581-2016 reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS)
Creator: LED Technologies, LLC
Published: 2016-03-30
License: https://open.fda.gov/license/

LED Technologies, Inc. / initiated 2016-03-30 / Terminated / root cause: manufacturing process

FDA source

LED Technologies, LLC began a recall of 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... on 2016-03-30. FDA classified it as Class II and gives the reason as "Incorrect Power Supply in the package, rendering the device inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1581-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-30
Posted: 2016-04-28
Terminated: 2016-11-30
Recalling firm: LED Technologies, Inc.
Product: 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.
Product code: ILY Lamp, Infrared, Therapeutic Heating
Reason for recall: Incorrect Power Supply in the package, rendering the device inoperable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 32 units
Distribution: Distributed to 1 consignee located in the United States.
Product codes and lots: Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1581-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1581-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code ILY

K081570Class IIDpl Therapy SystemLed Technologies, LLC / cleared 2008-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)