Class 2 Device Recall CellQuicken Analyzer, Brainvibe, Envirovibe, RoyalVibe

• Date Initiated by Firm: August 30, 2023
• Date Posted: October 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0082-2024
• Recall Event ID: 92789
• Product Classification: Focused ultrasound for tissue heat or mechanical cellular disruption - Product Code OHV
• Product: CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
• Code Information: CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
• FEI Number: 3022074304
• Recalling Firm/ Manufacturer: RoyalVibe Health Ltd.; 1095 Evergreen Cir Ste 200; The Woodlands TX 77380-3646
• For Additional Information Contact: Ryno van Tonder; 346-326-2866
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.