Events

Safety Alert for Non-Invasive System for Reduction of Fat Layers ZELTIQ

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zeltiq Aesthetics, Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1710-473
  • Event Number
    2010DM-0006502
  • Date
    2017-10-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=68
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data

Device

Non-Invasive System for Reduction of Fat Layers ZELTIQ
  • Model / Serial
    COOLSCULPTING, specific serials.
  • Product Description
    The ZELTIQ system provides a non-invasive method of reducing fat layers using controlled cooling in a precise and paramedical manner: volume of tissue visibly increased in size within the treatment zone, which can develop two to five months after treatment. A surgical intervention may be necessary.
  • Manufacturer
    Zeltiq Aesthetics, Inc

Manufacturer

Zeltiq Aesthetics, Inc