FDA recall Z-1943-2021

Inlightened Partners LLC · Class III · device

Product

inLight Medical LED Pads used with Polychromatic light technology system

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-06-04
Report date
2021-06-30
Termination date
2021-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Addison, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2021