LED Technologies Recalls reVive Light Therapy Devices Due to Power Supply Error
LED Technologies, LLC is recalling 32 units of the reVive Light Therapy Pain Relief Device because an incorrect power supply was included, rendering the devices inoperable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging error (incorrect power supply) that renders the device inoperable, with no risk of injury or harm, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
LED Technologies, LLC is recalling 32 units of the reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS). The recall is due to an incorrect power supply included in the package, which renders the device inoperable.
The affected units were manufactured between December 15, 2015, and December 28, 2015, and are associated with lot #1052. These devices were distributed to one consignee located in the United States.
The reVive Light Therapy Pain Relief Device is designed to deliver LED light spectrum in 880nm and 660nm directly into body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches, and strains. Consumers with this product should stop using it and contact the recalling firm for instructions.
The recalled product
- 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…
- Manufacturer
- LED Technologies, LLC
- Category
- Medical Device — Light Therapy
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052
Distribution
Distribution scope not specified by the agency.
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