Events

Safety Alert for Equipment PET - CT

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..

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
    I1501-9
  • Event Number
    2008EBC-0002089
  • Date
    2015-01-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=189
  • 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 states that the screen can be frozen in the course of the procedure without displaying any error message to alert the operator, leading to possible adverse events on patients.

Device

Equipment PET - CT
  • Model / Serial
    Model BIOGRAPH mCT and BIOGRAPH mCT Flow, serials 11002, 11005, 11006, 11008, 11042, 11021 and 1003, || VG50A versions.
  • Product Description
    Designed for full body oncology, neurology and cardiology exams. Its use must be carried out to determine various metabolic (molecular) and physiological functions of the human body and allows visual anatomical structures after converting x-ray patterns into visible images by computer.
  • Manufacturer
    Siemens Medical Solutions Usa, Inc.

Manufacturer

Siemens Medical Solutions Usa, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA