Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The U.S. Food and Drug Administration (FDA) has posted a medical device safety alert concerning : Solta Medical Inc THERMAGE CPT SYSTEM [Model number: TG-2B, UDI-DI Code: 00850608002124, Serial Number: 001933] [HKMD No.: 210387].
According to the FDA, a service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91847.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Apr 2023