The Recall Desk
HighFDA (Devices)·Z-3048-2017·Announced 2017-08-30

Solta Medical Recalls VASER PRO Amplifiers Due to Burn Risk

Solta Medical is recalling seven VASER PRO Amplifiers because a service depot repair may have caused inaccurate calibration, posing a risk of patient burns.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm (burns) to patients from a medical device, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Solta Medical Inc is recalling seven units of the VASER PRO Amplifier, part of the VASER 2.2 VASERlipo System. The device is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The recall affects units with specific serial numbers and was distributed to the states of Alabama, California, Colorado, Florida, New York, Pennsylvania, and Texas.

The recall was initiated because a service depot repair may have resulted in inaccurate calibration of the device. This potential defect could contribute to patients being burnt by the device during use. The issue only impacts units that were serviced between September 8, 2016, and May 23, 2017.

Healthcare providers and consumers should stop using the affected devices immediately. Solta Medical is the recalling firm responsible for addressing the issue. Users should contact the manufacturer for further instructions on repair or replacement.

The recalled product

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).
Manufacturer
Solta Medical Inc
Category
Medical Device — Aesthetic Body Contouring
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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.

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 recalled by Solta Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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