Aesthetics Biomedical recalls SUNG HWAN VIVACE devices due to unapproved high frequency output (2 MHz) not cleared for U.S. use. Affected units have serial numbers 16019-20121. No remedy specified in recall notice.
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Aesthetics Biomedical is recalling SUNG HWAN V:VIVACE devices that use unapproved high frequency output (2 MHz) for medical procedures. This poses a risk of serious injury because the frequency isn't cleared for U.S. medical use.
The device emits a high frequency output (2 MHz) that has not been approved by the U.S. for medical use. This unapproved frequency could cause serious injury during procedures like electrocoagulation or facial wrinkle treatment.
Medical professionals using the Vivace Electrosurgical System for dermatologic or surgical procedures are most at risk. Patients receiving these treatments may also be affected if the device is used improperly.
Check for serial numbers between 16019 and 20121 on the Vivace Electrosurgical System. The device is used for dermatologic and surgical procedures, including electrocoagulation and hemostasis.
Look for serial numbers between 16019 and 20121 on the Vivace Electrosurgical System.
The recall notice does not specify any remedy or fix for this device.
The device emits a high frequency output (2 MHz) not cleared for U.S. medical use, which could cause serious injury.
Check the serial number on the device; affected units have serial numbers from 16019 to 20121.
We’ve drafted a message you can send Aesthetics Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0444-2021 — Aesthetics Biomedical Aesthetics Biomedical Hello, I own a Aesthetics Biomedical that is covered by recall Z-0444-2021 from Aesthetics Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
