Z-0444-2021 Class II Terminated
FDA device recall Z-0444-2021 was initiated by Aesthetics Biomedical, Inc. on March 13, 2020 and is designated Class II. Reason for recall: A high frequency output (2 MHz) has not been cleared for distribution in the U.S. The recall status is terminated (terminated September 1, 2021). Affected quantity: 623 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2020
- Initiation Date
- March 13, 2020
- Termination Date
- September 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 623 units
Product Description
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.
Reason for Recall
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Distribution Pattern
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.
Code Information
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