BEUDAMED
    FDA Recall Terminated

    inLight Medical LED Pads used with Polychromatic light technology system

    Recall: Z-1943-2021 · Initiated June 4, 2019

    Recall

    Recall Number
    Z-1943-2021
    Event Number
    85106
    Firm
    Inlightened Partners LLC
    FEI Number
    3010709091
    Product Code
    ILY
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 4, 2019
    Terminated
    June 25, 2021
    Address
    16200 Addison Rd, Ste 105, Addison, TX, 75001-5302

    Description

    inLight Medical LED Pads used with Polychromatic light technology system

    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.

    Action

    On 6/5/2019, Medical Device Recall Letters were emailed to customers. Customers were instructed to examine the connector on the cord attached to their pad and compare it to photos provided in the Medical Device Recall Letter. The connectors for recalled product contain a v-shaped notch. Customers in possession of a pad with the connector matching the photos were requested to complete an Acknowledgement and Receipt Form. Customers with questions were asked to call Customer Service at 1-800-455-4116.

    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.

    Quantity

    926