BEUDAMED
    FDA Enforcement Class II Terminated

    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin

    Recall: Z-1176-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1176-2019
    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 Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin

    Reason

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

    Code Info

    Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096

    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

    177 devices of which 31 are affected