Events

Safety Alert for radiography system

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
    I1405-220
  • Event Number
    2008EBC-0002259
  • Date
    2014-05-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=203
  • 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 about a possible risk of accidental discharge of radiation as a result of filtration of the cleaning liquid in the generator console, which can lead to the occurrence of potentially adverse events on the patient or users.

Device

radiography system
  • Model / Serial
    Ysio
  • Product Description
    Imaging system for universal diagnosis for use in radiography, fluoroscopy, angiography and urology studies in adult and pediatric patients. It allows anatomical visual structures after converting x-ray patterns into visible images. It has medical applications in gastrointestinal, cranial, skeletal, thoracic, lung and urogenital exams.
  • Manufacturer
    Siemens A.G.

Manufacturer

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