Events

Safety Alert for Image acquisition system

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

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
    I1604-153
  • Event Number
    2008EBC-0001900
  • Date
    2016-04-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • 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 detectors that perform door or dynamic acquisitions may lose some time information, this means that the formulation of the image data and calculated ejection fraction values may be less than real, which could lead to potentially occurring events. adverse on the patients.

Device

Image acquisition system
  • Model / Serial
    e.cam, SYMBIA SERIE T, SYMBIA E, S SYMBIA and SYMBIA INTEVO
  • Product Description
    Image acquisition system that allows detecting or visualizing the distribution of radioactive nuclide absorption in the body or organ, making use of the following techniques: planar tomography, whole-body tomography, topographic imaging and imaging for isotopic conenergies up to 588kev. Detector heads easily rotate in numerous positions to offer general-purpose studies, cardiology, oncology and neurology.
  • Manufacturer
    Siemens Medical Solutions Usa, Inc. || Siemens Ag || Orbotech Medical Denmark

Manufacturer

Siemens Medical Solutions Usa, Inc. || Siemens Ag || Orbotech Medical Denmark
  • Source
    NIDFSINVIMA