Solta Medical Inc recalls VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended…

Recall date

June 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3048-2017

FDA classification

Class II

Brand / firm

Solta Medical Inc

Sold / distributed

US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, 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).