Events

Safety Alert for Equipment for Computerized Tomography

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, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems 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
    I1805-302
  • Event Number
    2017EBC-0000590-R1
  • Date
    2018-05-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=46
  • 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

Equipment for Computerized Tomography
  • Model / Serial
    OPTIMA CT660 and REVOLUTION EVO.
  • Product Description
    The equipment for GENERAL ELECTRIC tomography is designed to: obtain, process and offer images of different planes osections of the body taken at different angles and planes by X-ray technology that are reconstructed in the equipment as three-dimensional models of body structures for the diagnosis of whole body and of selected parts of the body in patients of all ages. Obtain, process and offer images of different planes or sections of the body taken at different angles and planes by means of X-ray technology that are reconstructed in the equipment as three-dimensional structures of the body in order to serve as a diagnostic tool for diseases, traumas or anomalies, as well as plan, guide and supervise the treatment. The system can be used as a diagnostic imaging support in minimally invasive procedures, such as biopsies and ablation of tumors and pathologies. The system can acquire anatomical CT (computed tomography) images that are useful in clinical terms for simulation and treatment planning.
  • Manufacturer
    Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.

Manufacturer

Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.