Events

Safety Alert for computed tomography equipment

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
    I1407-279
  • Event Number
    2008EBC-0001540
  • Date
    2014-07-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=201
  • 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
    The manufacturer reports that the equipment mentioned above may be outside the tolerance corresponding to radio frequency emissions, specifically at the frequency of 48 mhz, where tests result in 3.5db uv / m above the permitted in the applicable standard (iec 60601- 1-2), leading to possible variations in the results of the exams and electromagnetic interference surrounding other equipment.

Device

computed tomography equipment

Manufacturer

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