Recall Z-1581-2016 ยท ILY Lamp, Infrared, Therapeutic Heating
LED Technologies, LLC
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.
| Date | Apr 28, 2016 (initiated Mar 30, 2016) |
| Status | Terminated |
| Reason | Incorrect Power Supply in the package, rendering the device inoperable. |
| 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 | 32 units |
| Distribution | Distributed to 1 consignee located in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081570 | DPL THERAPY SYSTEM Led Technologies, LLC, Nov 7, 2008 |