Events

Safety Alert for X-ray diagnostic equipment

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 Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc || B.M. Tech Worldwide 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
    I1804-269
  • Event Number
    2008EBC-0002088
  • Date
    2018-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=49
  • 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

Device

X-ray diagnostic equipment
  • Model / Serial
    DPX-NT, DPX Bravo, DPX Duo, DPX-MD, Prodigy and Prodigy Advance
  • Product Description
    X-ray diagnostic equipment designed to measure the calcium content of the bone, examination called bone density or dual-energy x-ray absorptiometry or the bone densitometer is designed to calculate bone mineral density and body composition (lean or adipose tissue mass) ) of patients when their doctors indicate it.Obtain estimation of bone mineral density in several anatomic places (spine, femur, whole body and forearm. Obtaining an estimate of the risk of relative fracture based on the value of the t-score of the patient using Defracture risk categories defined by the World Health Organization (WHO). Fractures that appear in the instructions for use in the operation manual.
  • Manufacturer
    Ge Medical Systems Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc || B.M. Tech Worldwide Co., Ltd.

Manufacturer

Ge Medical Systems Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care...