Recall Z-0082-2024 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
RoyalVibe Health Ltd.
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
| Date | Oct 6, 2023 (initiated Aug 30, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| 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 attorney@royalvibehealth.com. |
| Quantity | 564 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.