Z-0082-2024 Class II Ongoing
FDA device recall Z-0082-2024 was initiated by RoyalVibe Health Ltd. on Aug 30, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 564.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 18, 2023
- Initiation Date
- Aug 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 564
Product Description
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
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 Pattern
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
Code Information
CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0082-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026