# FDA recall Z-3047-2017

> **Solta Medical Inc** · Class II · device recall initiated 2017-06-01.

## Product

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).

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-3047-2017
- **Recalling firm:** Solta Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-01
- **Report date:** 2017-08-30
- **Termination date:** 2020-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3047-2017

## Citation

> AI Analytics. FDA recall Z-3047-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3047-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*