Events

Safety Alert for X-Ray Equipment JUNO DRF - APOLO DRF

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..

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
    I1603-116
  • Event Number
    2010EBC-0006430
  • Date
    2016-03-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 an operator was injured at the moment of repositioning a table, when standing behind the patient platform between the left arm of the patient support platform and the sensor support, this situation was presented when entering an area restricted that does not constitute a habitual work position and the delayed activation of the emergency stop, leading to the occurrence of the adverse event on the user.

Device

X-Ray Equipment JUNO DRF - APOLO DRF
  • Model / Serial
    JUNO DRF and APOLO DRF
  • Product Description
    It is a universal table for radiological diagnosis, created to meet all needs. It can be used for examinations of the digestive system, skull and skeleton, urography, myelography, vascular and pulmonary exams, and it can also be used, when equipped with a digital camera for angiography.
  • Manufacturer
    Villa Sistemi Medicali S.P.A.

Manufacturer

Villa Sistemi Medicali S.P.A.