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
    I1605-204
  • Event Number
    2008EBC-0001540
  • Date
    2016-05-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=141
  • 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 the manufacturer reports that the referenced devices present the following series of drawbacks: 1) during the engraving operation in the software console of the mx16, the clipboard used to copy and paste images is not cleaned between patients. if the operator fails to copy the current patient's images before pasting them, the previous patient's images may be present on the new clipboard and copied to the current patient's recording.2) during scanning for bolus tracking, if the auto voice tracking function is enabled scanning by scanner will be aborted unexpectedly and the scanner after scanning will need to be manually initiated.3) if the scanner protocol with the sas (spiral autostart) function is selected to plan is scanned, the option sas could not be displayed in the scanner. contrast button in the protocol parameters area of the sas option scanner is not enabled as it is pre-configured in the protocol. this inconvenience only occurs in the first helical scanner after the system has been restarted by applying the sas function (this problem only occurs in the next scanner if a helical scanner has been executed after the system restart). if these situations occur, they could lead to potential events adverse to patients or delays in care.

Device

Computerized Tomography Equipment

Manufacturer

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