FDA Device recall Z-0444-2021
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures f…
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures f… by Aesthetics Biomedical, citing A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0444-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-13 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aesthetics Biomedical |
| Distribution | US |
Product
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
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Identifiers
| code_info | UDI Code: 08800017100326 All Lots/Serial Numbers: Serial Number range from 16019 to 20121. The Vivace Electrosurg…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0444-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.