Z-0082-2024Class II

CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water...

Name: Z-0082-2024 CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water...
Creator: RoyalVibe Health Ltd.
Published: 2023-08-30
License: https://open.fda.gov/license/

RoyalVibe Health Ltd. / initiated 2023-08-30 / Open, Classified

FDA source

RoyalVibe Health Ltd. began a recall of CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls on 2023-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0082-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-30
Posted: 2023-10-06
Recalling firm: RoyalVibe Health Ltd.
Product: CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Product code: OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
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 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 [email protected].
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
Product codes and lots: CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0082-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code OHV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)