The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3047-2017·Announced 2017-08-30

Solta Medical Recalls VASER Amplifiers Due to Burn Risk

Solta Medical is recalling four VASER Amplifier units because a service depot repair may have caused inaccurate calibration, posing a burn risk to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of burn injury to patients, which aligns with the rubric criterion for 'significant injury' reports, warranting a Severe classification.

Plain-English summary

Solta Medical Inc is recalling four units of the VASER 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 is due to a potential inaccurate calibration resulting from a service depot repair. This issue could contribute to patients being burnt by the device. The defect only impacts units that were serviced between September 8, 2016, and May 23, 2017.

The affected units were distributed in the United States to the states of Alabama, California, Colorado, Florida, New York, Pennsylvania, and Texas. The specific serial numbers for the recalled units are VAS10-0134, VAS13-0440, VAS12-0203, and 000TWY.

The recalled product

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).
Manufacturer
Solta Medical Inc
Category
Medical Device — Liposuction / Body Contouring
Hazard
Affected units
4

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 (7)

  • Reference No. 110-0021
  • Shipping P/N P007021-03
  • Device P/N P006982-03
  • Serial No. VAS10-0134
  • VAS13-0440
  • VAS12-0203
  • 000TWY.

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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