Solta Medical VASER Amplifier Recall: Inaccurate Calibration Risk
Solta Medical recalls VASER Amplifiers and systems from 2016-2017 due to potential inaccurate calibration after service, risking patient burns. Affected units were serviced between September 2016 and May 2017.
Lower-risk 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.
Contact the company
What happened, in plain English
Solta Medical is recalling VASER Amplifiers and related systems that were serviced between September 2016 and May 2017. Inaccurate calibration after service could cause patients to be burned by the device during treatments. Read more at govinfonow.com/recall/73989-solta-medical-vaser-amplifier-recall-inaccurate-calibration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73989-solta-medical-vaser-amplifier-recall-inaccurate-calibration-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3047-2017
Cite this page
“Solta Medical VASER Amplifier Recall: Inaccurate Calibration Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73989-solta-medical-vaser-amplifier-recall-inaccurate-calibration-risk. Based on FDA recall #Z-3047-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3047-2017%22&limit=1).
Why it’s dangerous
The device may become inaccurately calibrated after service by repair facilities, which could lead to patients being burned during treatments. This issue only affects units serviced between September 2016 and May 2017.
Who’s affected
Patients receiving body contouring treatments with the recalled VASER systems. Those who had the device serviced between September 2016 and May 2017 are most at risk.
How to tell if you have this one
Check if your VASER Amplifier or system was serviced between September 2016 and May 2017. Look for serial numbers like VAS10-0134, VAS13-0440, or VAS12-0203.
- Brand
Solta Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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 emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).; Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY. | 4 units |
| Z-3048-2017 | 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).; Reference No. 110-0032; Shipping P/N P007014-03; Device P/N P007023-03; Serial No. 001CW9, 000V1W, 000VBK, VAS10-0135-SB, 001FM0, 000TJ5, 00190Q. | 7 units |
What to do — step by step
Check Service Dates
Verify if your device was serviced between September 2016 and May 2017.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Colorado, Florida, New York, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3047-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3047-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.