FDA Device recall Z-3047-2017
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and em…
- FDA Device
- Class II
- terminated
- Published 2017-08-30
On 2017-08-30 the FDA classified a Class II recall of VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and em… by Solta Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3047-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-01 |
| Published | 2017-08-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Solta Medical |
| Distribution | AL, CA, CO, FL, NY, PA, TX |
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
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.
Identifiers
| code_info | Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3047-2017%22
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