PlainRecordsCellQuicken Analyzer (Smart-Watch and Software)…
- 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…
- Status
- Ongoing
- 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
- Enforcement report date
- Oct. 18, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- RoyalVibe Health Ltd.
- Product
- CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
- 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.
- 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
- Quantity
- 564
- Codes and lots
- CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
- Recall started
- Aug. 30, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-0082-2024
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls, FDA enforcement report, 2023-10-18. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Distributed in (FDA's record): Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Washington
This recall among the others
- FDA's enforcement report came 49 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0082-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0082-2024, Oct. 18, 2023. "CellQuicken Analyzer (Smart-Watch and Software)." PlainRecords, https://plainrecords.com/recall/device/z-0082-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections