Medical device recalls

Inlightened Partners LLC recalls inLight Medical LED Pads used with Polychromatic light technology system

Recall date
June 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1943-2021
FDA classification
Class III
Brand / firm
Inlightened Partners LLC
Sold / distributed
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.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

inLight Medical LED Pads used with Polychromatic light technology system

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