Events

Safety Alert for X-Ray Equipment for Surgery Arco in C

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

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
    I1509-439
  • Event Number
    2008EBC-0002441
  • Date
    2015-09-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=171
  • 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 has determined that an interruption in the generation of radiation caused by a malfunction of the equipment can be generated, emitting the error '' no radiofd restart '' when starting the system or connecting the arc to the monitor car, this error is still due to malfunctioning system and it is necessary to carry out a corrective intervention, which could lead to the potential occurrence of adverse events on the patient.

Device

X-Ray Equipment for Surgery Arco in C
  • Model / Serial
    CIOS ALPHA
  • Product Description
    These equipment are mobile radiography systems and digital image capture of a patient suitable for application in operating theaters, traumatology, cardiovascular surgery, gastroenterology, orthopedics and general surgery.
  • Manufacturer
    Siemens Ag.

Manufacturer

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