Recall Z-3047-2017— Solta Medical Inc

Name: FDA recall Z-3047-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Class II · Terminated

Class II FDA medical device recall by Solta Medical Inc, initiated 2017-06-01, terminated 2020-11-30. It names one FDA 510(k) clearance: K110306. Product: VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).. Reason: 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..

Recalling firm: Solta Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Terminated: 2020-11-30
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K110306 — SOUND SURGICAL VASER 2.1 LIPO SYSTEMSound Surgical Technologies, LLC·cleared 2011-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.