FDA-Device2021-06-30Class III
inLight Medical LED Pads used with Polychromatic light technology system
Inlightened Partners LLC
Hazard
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, TX, NC, ID, CO, VA, FL, VT, AK, DC, MA, IL, AZ, MN, IA, TN, WI, WA, OK, MI, OH, GA, NY, IN, PA, NV, NJ, AR, CO , LA, MT, OR, SD, ND, MD, UT, MO, KY, NM, KS, AS, NE, WY, PR, MS and the country of Canada.
Affected count
926
Manufactured in
16200 Addison Rd Ste 105, N/A, Addison, TX, United States
Products
inLight Medical LED Pads used with Polychromatic light technology system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2021Don't want to check this manually?
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