VASER PRO Amplifier — Class II medical device recall Z-3048-2017
Terminated recall by Solta Medical Inc, reported 2017-08-30, distributed in AL, CA, CO, FL, NY, PA, TX. Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by th
| Recall number | Z-3048-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Solta Medical Inc, Bothell, WA, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-08-21 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2020-11-30 |
| Distributed | AL, CA, CO, FL, NY, PA, TX |
| Quantity | 7 units |
| Serial numbers | 000TJ5, 000V1W, 000VBK, 00190Q, 001CW9, 001FM0, VAS10-0135-SB |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3048-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.