Events

Safety Alert for cardiovascular X-ray systems

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 Electronics India || Philips India Limited.

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
    I1610-409
  • Event Number
    2008EBC-0002432
  • Date
    2016-10-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • 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 informs that the generator's breathing valve could be in the wrong position resulting in a failure of the ht tank, which would cause an interruption of the operation during the procedure, leading to potential adverse events on the patients.

Device

cardiovascular X-ray systems
  • Model / Serial
    ALLURA FC and INTUIS, references 723003, 723001 and 723005, specific serials.
  • Product Description
    Monoplane or biplane systems used for diagnostic and interventional cardiovascular procedures, which have a stand with a C-suspended arm and digital image acquisition technology. Indicated for the diagnosis of cardiovascular diseases. It can also be used for diagnosis in surgical procedures and treatment for the placement of stents, demarcated implants in people of all ages.
  • Manufacturer
    Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited

Manufacturer

Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA