BEUDAMED
    FDA Recall 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 · Initiated December 10, 2018

    Recall

    Recall Number
    Z-1176-2019
    Event Number
    82346
    Firm
    ProSun International, LLC
    FEI Number
    1000525872
    Product Code
    LEJ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 10, 2018
    Terminated
    May 2, 2023
    Address
    2442 23rd St N, Saint Petersburg, FL, 33713-4018

    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.

    Action

    ProSun initially notified customers on about 12/10/2018 via "URGENT: POTENTIAL UV EXPOSURE DISCREPANCY" letter. Instructions included to contact ProSun Customer Service at 727-825-0400 Ext 243 or 224 or by email at [email protected] to coordinate receipt of a UV meter to verify UV output. Once received, customers should take the requested UV readings, fill out the form accompanying the UV meter, and return the UV meter with signed form via the enclosed return label. If there are any out-of-specification readings present, ProSun will contact that customer with a solution. Another customer notification was sent to customers on about 3/11/19 via "URGENT: Urgent Recall Notice" letter. Instructions included were the same as the 12/10/18 letter. Customers who were initially contacted via telephone call received a follow up letter with the same instructions. If you have any questions, Contact ProSun Customer Service at 727-825-0400 Ext 224.

    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