BEUDAMED
    FDA Recall Open, Classified

    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls

    Recall: Z-0082-2024 · Initiated August 30, 2023

    Recall

    Recall Number
    Z-0082-2024
    Event Number
    92789
    Firm
    RoyalVibe Health Ltd.
    FEI Number
    3022074304
    Product Code
    OHV
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 30, 2023
    Posted
    October 6, 2023
    Address
    1095 Evergreen Cir, Ste 200, The Woodlands, TX, 77380-3646

    Description

    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls

    Reason

    Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.

    Action

    On 8/30/23, customers were mailed recall notices and told to do the following: Cease use and disconnect all cables. Please package securely in the return packaging provided and promptly return via parcel post, without discarding any part of it or accessories. Also, complete and return the Recall Return Response Form enclosed. Customers with questions about this recall can call (832) 742 6292, Monday through Friday, between 9:00 AM and 4:00 PM, Central Time or email [email protected].

    Distribution

    US: MI, PA, TX, GA, OH, CA, FL, NY, NH, UT, AL, WA. WI, MN, MA, NM, IA, MD, IL, SC, NJ, NC, NV, TN, AZ, OR, OK, LA, OR, NE, ME, CO, MS, MT, CT, KY, HI, IN, DC

    Quantity

    564