Reported Nov 18, 2020 · Terminated
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and…
Aesthetics Biomedical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesthetics Biomedical, Inc. · 4602 N 16th St Ste 300 · Phoenix, AZ · 85016-5162
Is this the product you have?
- SUNG HWAN E&B VIVACE Shenb Innovation
- of Beauty Technologyt - Product Usageintended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles
- Lot codes and dates
- UDI Code08800017100326
- All Lots/Serial NumbersSerial Number range from 16019 to 20121. The Vivace Electrosurgical
- System is controlled by software system
VIVA-MA-01V 1.0Class B
- Amount recalled
- 623 units
Where it was sold
Why it was recalled
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
This product could cause temporary or reversible health problems — stop using it.
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