Events

Safety Alert for X-ray computed tomography equipment - CT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Medical Systems (Cleveland) Inc. || Philips And Neusoft Medical System.

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
    I1401-10
  • Event Number
    2008EBC-0001540
  • Date
    2014-01-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=212
  • 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 was stated by the manufacturer that during the procedure corresponding to the monitoring of a bolus with a clinical rotation stage of 0.4 seconds, in the references of the aforementioned biomedical equipment that makes use of the software version 3.6.0, opacity may occur taking of the test, which may lead to overuse of unnecessary radiation to the patient.

Device

X-ray computed tomography equipment - CT

Manufacturer

Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland...
  • Source
    NIDFSINVIMA