Events

Safety Alert for single-photon emission computerized tomograph Spect E.CAM /SYMBIA

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 A.G. || 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
    I1603-126
  • Event Number
    2008EBC-0001900
  • Date
    2016-03-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 it has detected incidents that occurred during collimator change operations that led to the injury of the user, and found that although the user manual is effective, it seems that additional instructions such as visual aids could help to make the change procedure of the collimator more secure , which could potentially reduce the presentation of adverse events on users.

Device

single-photon emission computerized tomograph Spect E.CAM /SYMBIA
  • Model / Serial
  • Product Description
    Image acquisition system that allows detecting or visualizing the distribution of radionuclide 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 A.G. || Orbotech Medical Denmark

Manufacturer

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