InLight Medical Notice
This notice is to inform customers InLight Medical is initiating a voluntary recall of certain InLight LED Pads due to a potential for the power supply to shut down.
MEDICAL DEVICE RECALL
INLIGHT MEDICAL, LLC
June 5, 2019
The purpose of this notice is to inform customers that InLight Medical (“InLight” or the “company”) is initiating a voluntary recall of certain InLight LED Pads due to a potential for the power supply to shut down. This recall is expected to last for a period of 60 days from the date of this notice. The InLight Device supplies a pulsed light emitting diode (LED) providing a temporary increase in local circulation and temporary relief of minor pain. The product is intended to provide LED light associated gentle warmth (limited temperature elevation) therapy to (1) temporarily relieve minor pain, stiffness and muscle spasms; and (2) to temporarily increase the local blood circulation.
The company has received a limited number of complaints associated with this issue and has determined that a connection may not have been assembled properly on a LED pad that may have been purchased. This issue could lead to a power interruption, causing the controller and power supply to shut down.
To date, InLight has not received any reports of customer impact as a result of this issue. This shutdown function serves as a safety feature that is built into our device and indicates that the product is working as designed. Due to significant safety features built into the device, we are confident that chances of injury as a result of this issue are extremely low. However, the company has initiated this action in an abundance of caution.
The connector on the cord attached to a pad contains a “v-shaped notch” and is easily identifiable (see photos below).
Any customer with a pad that has a connector matching the photos above, please contact InLight according to the instructions in this letter. Upon posting of this notice, customers have 60 days to contact InLight Customer Service at 1-888-455-4116 for product return instructions. Customers may also email email@example.com
Questions arising as to whether a cable is correct or incorrect can be directed to the InLight Customer Service line at 1-888-455-4116 and we will assist in identifying the connector.
InLight was founded upon the highest principles of customer service. Our company will refurbish or replace any pad purchased with the cable connection that is the subject of this action. InLight values all of our customers and regrets the inconvenience this may have caused.
InLight reminds all customers that adverse reactions or quality problems experienced with the use of this product may be reported to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.