BEUDAMED
    FDA Recall Open, Classified

    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

    Recall: Z-2636-2023 · Initiated March 31, 2023

    Recall

    Recall Number
    Z-2636-2023
    Event Number
    92217
    Firm
    J & T Health and Wellness LLC
    FEI Number
    1000525872
    Product Code
    LEJ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    March 31, 2023
    Posted
    September 28, 2023
    Address
    2442 23rd St N, Saint Petersburg, FL, 33713-4018

    Description

    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

    Reason

    In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.

    Action

    ProSun INTERNATIONAL notified their consignees by email on 04/19/2023 a potential safety issue with their tanning beds. The notice explained the issue and requested the consignee cease use until the correction of the device can be conducted.

    Distribution

    US

    Quantity

    12 units