BEUDAMED
    FDA Enforcement Class III Terminated

    inLight Medical LED Pads used with Polychromatic light technology system

    Recall: Z-1943-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1943-2021
    Event ID
    85106
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inlightened Partners LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 30, 2021
    Initiation Date
    June 4, 2019
    Classification Date
    June 24, 2021
    Termination Date
    June 25, 2021
    Address
    16200 Addison Rd Ste 105, N/A, Addison, TX, 75001-5302, United States

    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.

    Code Info

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

    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