Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VASER Amplifier Recalled by Solta Medical Inc Due to Potential inaccurate calibration by service depot repair, which...

Date: June 1, 2017
Company: Solta Medical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Solta Medical Inc directly.

Affected Products

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).

Quantity: 4 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 7 states: AL, CA, CO, FL, NY, PA, TX

Affected (7 states)Not affected

About Solta Medical Inc

Solta Medical Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report