Solta Medical Recalls
5 recalls on record · April 23, 2014 to April 19, 2023 · Medical Devices
Recalls by year
14
17
20
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 19, 2023Medical DevicesFDA
Solta Medical Inc recalls thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.
Hazard: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
April 15, 2020Medical DevicesFDA
Solta Medical Inc recalls Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF
Hazard: 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.
August 30, 2017Medical DevicesFDA
Solta Medical Inc recalls VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intend
Hazard: Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
August 30, 2017Medical DevicesFDA
Solta Medical Inc recalls VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for th
Hazard: Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
April 23, 2014Medical DevicesFDA
Solta Medical, Inc. recalls FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Hazard: Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.