Recall Z-1354-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Solta Medical Inc
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of t
| Date | Apr 7, 2023 (initiated Feb 16, 2023) |
| Status | Open, Classified |
| Reason | A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. |
| Root cause | Process control |
| Action | On 02/16/2023, the firm contacted customer via telephone e and then coordinate shipping out a loaner device as well as getting the unit (s/n: 001933) back for retest and possible recalibration. Documentation for the recall will be mailed with the loaner system to the customer. If you have any questions, contact Senior Director, Global Product Support at 425-420-2352 or email: Jody.Johnson@solta.com. |
| Quantity | 1 unit |
| Distribution | U.S. Distribution to state of: MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173759 | Thermage CPT System and Accessories Solta Medical, Jan 8, 2018 |