medical Class II Updated 2023-10-18

RoyalVibe Health Ltd. recalls CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, NE, ME, CO, MS, MT, CT, KY, HI, IN, DC
Lot/Code Info: CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
View official government recall

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