BEUDAMED
    FDA Enforcement Class II Terminated

    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY

    Recall: Z-1177-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1177-2019
    Event ID
    82346
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ProSun International, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    December 10, 2018
    Classification Date
    April 16, 2019
    Termination Date
    May 2, 2023
    Address
    2442 23rd St N, N/A, Saint Petersburg, FL, 33713-4018, United States

    Description

    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY

    Reason

    ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

    Code Info

    Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430

    Distribution

    US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.

    Quantity

    250 devices of which 9 are affected