Aesthetics Biomedical Recalls Vivace Electrosurgical System for Regulatory Violation
Aesthetics Biomedical is recalling 623 Vivace Electrosurgical Systems because a high-frequency output was not cleared for U.S. distribution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The source text does not report any illnesses, injuries, or deaths, and the hazard is a regulatory clearance issue rather than a direct physical defect causing harm.
Plain-English summary
Aesthetics Biomedical, Inc. is recalling 623 units of the SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technology. This medical device is intended for use in dermatologic and surgical procedures for electrocoagulation and hemostasis, as well as the percutaneous treatment of facial wrinkles.
The recall was initiated because a high-frequency output (2 MHz) of the device has not been cleared for distribution in the United States. The affected units are identified by UDI Code 08800017100326 and serial numbers ranging from 16019 to 20121. The device is controlled by software system VIVA-MA-01, V 1.0, Class B.
The product was distributed nationwide across the United States, including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Users should stop using the device and contact the recalling firm for instructions.
The recalled product
- Product
- SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
- Manufacturer
- Aesthetics Biomedical, Inc.
- Hazard
- Affected units
- 623
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- V 1.0
- Class B
Distribution
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