Solta Medical thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF recall — FDA Z-1354-2023
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Overview of recall records associated with Solta Medical Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
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.
This page summarizes recall records in which the official source identifies Solta Medical Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.