Recall Z-0444-2021 ยท OUH Skin Resurfacing Rf Applicator
Aesthetics Biomedical, Inc.
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.
| Date | Mar 13, 2020 |
| Status | Terminated |
| Reason | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. |
| Root cause | No Marketing Application |
| Action | On 03/13/2020, the firm sent a customer notification letter via USPS informing customer that it was discovered that their RF Microneedling device contains the 2 MHz power level that has not been cleared for use within the United States. The Recalling Firm is offering the following offers: 1) Customers may have the 2MHz capability disabled until regulatory clearance is received. The Recalling Firm will arrange, at their expense, a convenient time with the customer's office to take this action. The planned field correction includes a replacement CPU to disable 2MHz functionality, but also provi |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150409 | VIVACE Electrosurgical System Sung Hwan E&B Co.,Ltd, Jan 15, 2016 |