Events

Recall of VASER SYSTEM - VASER AMPLIFIER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VALEANT CANADA LP/VALEANT CANADA S.E.C.

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
    27860
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Solta medical is conducting a voluntary recall of the vaser amplifier that were returned to the solta bothell washington service depot for repair between september 8/2016 and may 23/2017 due to the potential that the device was inaccurately tuned by the service depot during repair. the use a product in the affected range constitutes a potential risk and could contribute to burns.

Device

VASER SYSTEM - VASER AMPLIFIER
  • Model / Serial
    Model Catalog: 110-0032 (Lot serial: SN 0019XJ); Model Catalog: 110-0032 (Lot serial: SN 000V9Z)
  • Product Description
    Vaser Amplifier
  • Manufacturer
    VALEANT CANADA LP/VALEANT CANADA S.E.C

Manufacturer

VALEANT CANADA LP/VALEANT CANADA S.E.C