Events

Safety Alert for CO2 Laser Acupulse and Ultrapulse - Lumenis

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

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
    I1611-532
  • Event Number
    2010EBC-0005950 ; 2015EBC-0013696
  • Date
    2016-11-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • 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
  • Reason
    The manufacturer reports that he initiated a new verification of the cleaning protocol, the results of which showed that the current protocol, as indicated in the instructions of use (ifu), is not efficient for the assembly and assembly of the kits and handpieces femtouch, which could lead to the occurrence of potentially adverse events on patients.

Device

CO2 Laser Acupulse and Ultrapulse - Lumenis
  • Model / Serial
    AcuPulse DUO CO2, AcuPulse and AcuScan120, concerning the FemTouch Kit and FemTouch Handpiece systems.
  • Product Description
    The CO2 laser can be used effectively in soft tissue removal, incision, ablation, vaporization and coagulation. This CO2 laser system excited by DC (direct current) is designed for various procedures, aesthetic, surgical and general surgery.
  • Manufacturer
    Lumenis Ltd

Manufacturer

Lumenis Ltd