Events

Safety Alert for Philips digital fluoroscopy and X-ray system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Villa Sistemi Medicali S.P.A. || Dunlee División Of Philips Medical Systems (Cleveland) Inc. || Philips Medical Systems Nederland B.V..

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
    I1607-278
  • Event Number
    2009EBC-0004752
  • Date
    2016-07-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 two bolts that attach the plate to the lateral axis can break, this can cause the c-arm to move freely and depending on the orientation of the c-arm it can move laterally forward, slide out of its supports and possibly fall , leading to the occurrence of potential adverse events on patients or users.

Device

Philips digital fluoroscopy and X-ray system

Manufacturer

Villa Sistemi Medicali S.P.A. || Dunlee División Of Philips Medical Systems (Cleveland) Inc. || P...