BEUDAMED
    FDA Recall Terminated

    Sundream 12 V tanning bed

    Recall: Z-0319-2018 · Initiated December 2, 2017

    Recall

    Recall Number
    Z-0319-2018
    Event Number
    78571
    Firm
    ProSun International, LLC
    FEI Number
    1000525872
    Product Code
    LEJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2017
    Terminated
    February 18, 2026
    Address
    2442 23rd St N, Saint Petersburg, FL, 33713-4018

    Description

    Sundream 12 V tanning bed

    Reason

    The 30 minute maximum tanning time has been reduced to 20 minutes.

    Action

    Customers were initially notified of the recall on 03/24/2016 and then again on 10/17/2017. Instructions included to check current inventory for the affected device and complete and return the response card to ProSun who will then supply a set of 12 lower output lamps that are rated at 30 minutes maximum tanning time, provide a new Owner's Manual, and a new Tanning Schedule Label with the new 30 min lamps listed.

    Distribution

    Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI

    Quantity

    75 units