Solta Medical Inc: Medical Device Recall in 2017 - (Recall #: Z-3047-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: June 1, 2017

Date Posted: August 30, 2017

Recall Number: Z-3047-2017

Event ID: 77655

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.

Status: Terminated

Product Quantity: 4 units

Code Information:

Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated