Events

Safety Alert for Digital X-ray systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Philips Medical Systems Dmc Gmbh || Philips Healthcare (Suzhou) Co., Ltd || Philips India Limited-India.

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
    I1606-261
  • Event Number
    2009EBC-0005021
  • Date
    2016-06-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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 informs that if the volume of the monitor is turned off, the absence of an audible signal from completion to exposure could lead the operator to assume that the exposure was not executed correctly and therefore proceed to an unnecessary repetition of the exposure of x-rays , leading to the occurrence of potential adverse events on patients.

Device

Digital X-ray systems

Manufacturer

Philips Medical Systems Dmc Gmbh || Philips Healthcare (Suzhou) Co., Ltd || Philips India Limited...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA