Recall Z-1681-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Solta Medical Inc
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
| Date | Dec 30, 2019 |
| Status | Terminated |
| Reason | Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns. |
| Root cause | Process design |
| Action | On 12/30/2019, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" to customers via registered mail to inform them that they have become aware that there is a potential problem related to their device that may result in patient burns. This recall affects 20 lots manufactured and distributed between 08/14/2019 and 12/12/2019. The firm is instructing the customers to: 1. Review their inventory for all devices impacted by this voluntary recall and remove them from the inventory. 2. The manufacturer/ recalling firm is asking their customers to contact Customer Service at 1-877-782-2286 o |
| Quantity | 4472 units |
| Distribution | US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132431 | THERMAGE CPT SYSTEM Solta Medical, Inc., Sep 6, 2013 |