Z-1581-2016 Class II Terminated
FDA device recall Z-1581-2016 was initiated by LED Technologies, LLC on March 30, 2016 and is designated Class II. Reason for recall: Incorrect Power Supply in the package, rendering the device inoperable. The recall status is terminated (terminated November 30, 2016). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 30, 2016
- Termination Date
- November 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
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.
Reason for Recall
Incorrect Power Supply in the package, rendering the device inoperable.
Distribution Pattern
Distributed to 1 consignee located in the United States.
Code Information
Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052