Events

Safety Alert for Computerized 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 And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Healthcare (Suzhou) Co., Ltd || Philips Medical Systems (Cleveland) Inc..

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
    I1603-117
  • Event Number
    2008EBC-0001540
  • Date
    2016-03-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 varian rpm unit is not assigned to the user profile after starting / closing session, the unit mapping function assigns the varian unit using all the credentials of the unit in the login service and then creates a script that maps with all the varian credentials in the user of the ct system, once the script is executed in the logon of thect system and the user recognizes the successfully mapped unit, the script deletes itself, in subsequent starts, the unit will not connect due that the varian credentials will no longer be available, if this situation occurs, the user will not be able to execute closed pulmonary scans, leading to the occurrence of potential adverse events on the patients.

Device

Computerized Tomography Equipment

Manufacturer

Philips And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee D...
  • Source
    NIDFSINVIMA