Events

Safety Alert for Intraoral X-ray Generator System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Trophy For Carestream Health, 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
    I1402-86
  • Event Number
    INVIMA 2009EBC-0003256
  • Date
    2014-02-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=208
  • 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 the articulation of the mechanical system between the scissor arm and the support could fail prematurely, due to a manufacturing problem for the models mentioned and that were manufactured between may 2008 and april 2010, leading to the occurrence of potentially adverse events. the patient or the user.

Device

Intraoral X-ray Generator System
  • Model / Serial
    Kodak 2100 and Kodak 2200
  • Product Description
    Radiological unit that aims to capture and analyze high quality intraoral dental radiographs
  • Manufacturer
    Trophy For Carestream Health, Inc

Manufacturer

Trophy For Carestream Health, Inc
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    NIDFSINVIMA