Events

Safety Alert for magnetic resonance equipment

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 Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd..

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 Number
    2018EBC-0017485
  • Date
    2018-04-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • 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

Device

magnetic resonance equipment
  • Model / Serial
    T5, T10-NT, ACSNT, Intera 0.5T / 1.0T / 1.5T, Achieva 1.5T, Multiva 1.5T
  • Product Description
    The intended use of PHILIPS MRI medical electromedical systems is class IIa diagnostic equipment. The systems can generate transverse and spectroscopic images in any orientation of the internal structure of the head, body or extremities. Magnetic resonance images represent the spatial distribution of protons or other nuclei with spin. The appearance of the images is determined by different physical properties of tissue and anatomy, and the technique of acquisition by applied MRI. The image acquisition process can be synchronized with the patient's breathing or with the cardiac cycle. The systems can use combinations of images to generate physical parameters and related derived images. The images, the spectra, and the measurements of physical parameters, after being interpreted by the medical specialist, provide information that can facilitate the diagnosis and planning of the therapy. The accuracy of certain physical parameters depends on the system and the acquisition parameters, and must be regulated and validated by the clinical user. For some studies, the use of contrast media may be essential. During an MRI exam, energy is transferred to the patient in the form of radio frequency waves, changing magnetic fields and acoustic noise. The PHILIPS magnetic resonance systems do not emit radiation-ionizing agents. Non-invasive diagnostic equipment
  • Manufacturer
    Philips Medical Systems Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd.

Manufacturer

Philips Medical Systems Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA