Events

Safety Alert for surgical lamp

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Trumpf Medizin Systeme Gmbh + Co. Kg..

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
    I1509-436
  • Event Number
    2014DM-0011439
  • Date
    2015-09-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=171
  • 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 has determined that there may be a possibility that the welds of the anterior elastic arms may develop fatigue fractures with time when exposed to extreme forces, which could lead to the occurrence of potentially adverse events on the patient or users.

Device

surgical lamp
  • Model / Serial
    Iled 3 and Iled 5
  • Product Description
    This device is used to illuminate a zone of the patient who was examining or operating in hospitals or medical consultations locally with a high luminous intensity.
  • Manufacturer
    Trumpf Medizin Systeme Gmbh + Co. Kg.

Manufacturer

Trumpf Medizin Systeme Gmbh + Co. Kg.