Solta Medical Inc: Medical Device Recall in 2017 - (Recall #: Z-3048-2017)

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 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).

Product Classification:

Class II

Date Initiated: June 1, 2017

Date Posted: August 30, 2017

Recall Number: Z-3048-2017

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: 7 units

Code Information:

Reference No. 110-0032; Shipping P/N P007014-03; Device P/N P007023-03; Serial No. 001CW9, 000V1W, 000VBK, VAS10-0135-SB, 001FM0, 000TJ5, 00190Q.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated