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.
Check against the official notice below — it lists the full affected range.
Aesthetics Biomedical, Inc. is recalling the SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technology electrosurgical system used in dermatologic and surgical procedures. The recall affects 623 units distributed nationwide across all U.S. states and territories. The devices have serial numbers ranging from 16019 to 20121 and are identified by UDI Code 08800017100326.
The reason for the recall is that the device's high frequency output at 2 MHz has not been cleared for distribution in the United States. The source document does not specify any remedy or actions consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Reason for recall: A high frequency output (2 MHz) has not been cleared for distribution in the U.S. Distribution: 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. Quantity: 623 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.