Events

Safety Alert for X-ray mobile equipment without fluoroscopy

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sedecal S.A. (sociedad española de electromedicina y calidad || s.a.) || GE Healthcare || GE Medical Systems.

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
    I1402-53
  • Event Number
    2008EBC-0002158
  • 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 at the time of extracting from the hospital information system (his / ris) a large number of examinations of different patients, the examinations may not correspond to the correct patient, leading to diagnostic errors and potentially adverse events on the patient. patient.

Device

X-ray mobile equipment without fluoroscopy

Manufacturer

Sedecal S.A. (sociedad española de electromedicina y calidad || s.a.) || GE Healthcare || GE Medi...
  • Source
    NIDFSINVIMA