FDAFDA · Food and drugs·Recall number Z-0444-2021
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.
Published November 18, 2020 · Recall initiated: March 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Aesthetics Biomedical, Inc.
- Distributor
- U.S. Nationwide distribution 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.
- Lot
- UDI Code: 08800017100326 All Lots/Serial Numbers: Serial Number range from 16019 to 20121. The Vivace Electrosurgical System is controlled by software system: VIVA-MA-01, V 1.0, Class B
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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