Class II — Solta Medical Inc
| Recalling firm | Solta Medical |
|---|---|
| Registered facility | Solta Medical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | 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). |
| Quantity | 7 units |
| Distribution | US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX. |
| Initiated | 2017-06-01 |
| Classified | 2017-08-21 |
| Terminated | 2020-11-30 |
| Recall number | Z-3048-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Solta Medical Inc (Z-3048-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77655/
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