Events

Safety Alert for mobile X-ray systems in C

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Oec Medical Systems 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
    I1410-415
  • Event Number
    2009EBC-0003260
  • Date
    2014-10-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=194
  • 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 states that it has detected that various components of the previous systems may have been replaced with previous versions, causing security risks and leading to possible adverse events for patients or users.

Device

mobile X-ray systems in C
  • Model / Serial
    OEC 9800, OEC UroView 2800, FlexiView 8800, OEC MiniView 6800, specific serial
  • Product Description
    X-ray systems or "mobile arcs in C" are general purpose diagnostic equipment, with mobility around the operation or examination table, based on X-ray technology that allows: obtaining and / or recording of fixed images (conventional radiography and digital) internal structures of the body by exposing a part of the body to a small dose of lightning rods x; the obtaining and / or recording of moving images in real time (continuous, pulsed or instantaneous fluoroscopy) and the video capture of the patient's internal structures as support during diagnostic, surgical procedures and intervention procedures. These equipments are designed to visualize anatomical structures converting a X radiation pattern in a picture visible through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, cardiac and neurological neurology, including the implantation of heart rhythm management devices, calculus localization, chest surgery, gastrointestinal tract investigations, angiography of the leg vessels, heart and brain, and can be used for other applications of imaging doctor adiscretion
  • Manufacturer
    GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Oec Medical Systems Inc

Manufacturer

GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Oec Medical Systems Inc