CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
- Company
- Royalvibe Health Ltd.
- Recall Initiated
- August 30, 2023
- Posted
- October 6, 2023
- Recall Number
- Z-0082-2024
- Quantity
- 564
- Firm Location
- The Woodlands, TX
Reason for Recall
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.
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
Lot / Code Info
CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
Root Cause
Under Investigation by firm
Action Taken
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 attorney@royalvibehealth.com.