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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
Recalled August 30, 2017 · FDA recall Z-3048-2017 · Solta Medical
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. · FDA Class II
Units
7 units
Sold at
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
Description
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.
Product
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).
Manufacturer(s)
Solta Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →