Events

Safety Alert for X-ray equipment for surgery arch

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens A.G..

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
    I1603-89
  • Event Number
    2008EBC-0002441
  • Date
    2016-03-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • 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 states that it has detected that the system can detect failures in the patient's date of birth format, system failures during dvd burning, and occasional interruptions in the operation surrounding the car to the main unit, leading to potential events adverse effects on the patient or delays in the execution of procedures.

Device

X-ray equipment for surgery arch
  • Model / Serial
    ALPHA CIOS, all serials.
  • Product Description
    These equipment are mobile radiography systems and digital image capture of a patient suitable for application in operating theaters, traumatology, cardiovascular surgery, gastroenterological surgery, orthopedics and general surgery.
  • Manufacturer
    Siemens A.G.

Manufacturer

Siemens A.G.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA