Events

Recall of Device Recall Lipoplasty

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Solta Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77655
  • Event Risk Class
    Class 2
  • Event Number
    Z-3048-2017
  • Event Initiated Date
    2017-06-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157189
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • 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.
  • Action
    Consignees were telephoned on June 1, 2017, as initial recall notification. At that time, all consignees agreed to discontinue use of the affected product until it was returned or repaired. An Urgent Medical Device Recall letter dated June 14, 2017, requested that consignees that have not been contacted regarding this recall and have a device repaired between the dates of 09/08/2016 and 05/23/2017 contact Solta Medical immediately at 877-782-2286. Any questions regarding the recall can be directed to Solta Medical Product Support Team at 877-782-2286 or 510-259-5299, option 2.

Device

Device Recall Lipoplasty
  • Model / Serial
    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
    US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
  • Product Description
    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

Manufacturer

Solta Medical Inc
  • Manufacturer Address
    Solta Medical Inc, 11720 N Creek Pkwy N Ste 100, Bothell WA 98011-8244
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA