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Recall Observatory FDA recall evidence

Device product

inLight Medical LED Pads used with Polychromatic light technology system

Z-1943-2021

June 04, 2019

Class III

Product summary

Firm
Inlightened Partners LLC
Event
Event 85106
Status
Terminated
Classification
Class III
Quantity
926
Official record key
device-enforcement:Z-1943-2021

Official wording

Reason: 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.

Code information: All serial numbers with cord connectors that have v-shaped notches

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.