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.
Reported: November 18, 2020 Initiated: March 13, 2020 #Z-0444-2021
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.
Details
- Recalling Firm
- Aesthetics Biomedical, Inc.
- Units Affected
- 623 units
- 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.
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aesthetics Biomedical, Inc.. Units affected: 623 units.
Why was this product recalled? ▼
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0444-2021.
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