reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Devi
FDA device recall Z-1581-2016 · posted 2016-04-28 · Terminated
Recall details
- Recalling firm
- LED Technologies, LLC
- Reason for recall
- Incorrect Power Supply in the package, rendering the device inoperable.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- ILY
- Quantity affected
- 32 units
- Distribution
- Distributed to 1 consignee located in the United States.
- Date initiated
- 2016-03-30
- Date posted
- 2016-04-28
- Date terminated
- 2016-11-30
- Location
- Greenwood Village, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DPL THERAPY SYSTEM (K081570) | Led Technologies, LLC | 2008-11-07 |