Events

Safety Alert for Digital diagnostic x-ray system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Samsung Electronics Co., 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
    I1402-54
  • Event Number
    2012EBC-0009015
  • Date
    2014-02-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=210
  • 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
    It is reported by the manufacturer that despite performing the normal operation of the unit and after releasing the remote control switch, an uncontrolled movement of the x-ray tube head is presented which is moved to its maximum limit and the "code of error 4308 ", leading to the potential occurrence of adverse events on the patient bear the operator.

Device

Digital diagnostic x-ray system
  • Model / Serial
    XGEO GC80, GC80V80
  • Product Description
    It has been designed to capture digital images by x-rays of various parts of the body, including the head, chest, spine, abdomen, joints, hands, feet and other organs. It has not been designed to perform mammograms.
  • Manufacturer
    Samsung Electronics Co., Ltd

Manufacturer

Samsung Electronics Co., Ltd