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RoyalVibe Health Ltd. recalls CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct
Recalled October 18, 2023 · FDA recall Z-0082-2024 · RoyalVibe Health
Hazard
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. · FDA Class II
Units
564
Sold at
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
Description
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.
Product
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Manufacturer(s)
RoyalVibe Health Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →