Events

Safety Alert for Pet/CT Philips

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by PHILIPS Medical Systems (Cleveland) 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
    A1402-66
  • Event Number
    INVIMA 2008EBC-0001538
  • Date
    2014-02-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=209
  • 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
    It is reported that the pet reconstruction server (prs) can be blocked after the acquisition of ct in low doses and may not allow the acquisition of pet, which would result in incomplete cases, therefore potential for erroneous diagnoses and adverse events on the patient.

Device

Pet/CT Philips
  • Model / Serial
    GEMINI TF 16 PET/CT and GEMINI TF 64 PET/CT
  • Product Description
    Positron emission tomography technology and x-ray computed tomography.
  • Manufacturer
    PHILIPS Medical Systems (Cleveland) Inc.

Manufacturer

PHILIPS Medical Systems (Cleveland) Inc.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA