CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct
Summary
The FDA issued a Class II for CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator by RoyalVibe Health Ltd.. Reason: Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. .
Details
Source
Device Recall
External ID
Z-0082-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
Lot/Code Info: CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.
Quantity Affected: 564
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-30
Company
The Woodlands, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RoyalVibe Health Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RoyalVibe Health Ltd. have FDA actions?
This is the only FDA action we have on record for RoyalVibe Health Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0082-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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