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
    I1606-262
  • Event Number
    2008EBC-0002432
  • Date
    2016-06-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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 some power cables could be subject to an increase in the probability of failure, which could result in the sudden loss of the function of images or mechanical movements, depending on the subsystem to which it is feeding, leading to the presentation of potential adverse events. patients and users or delays in the procedure.

Device

cardiovascular X-ray systems
  • Model / Serial
    ALLURA XPER SERIES, software version R8.2, specific serials.
  • Product Description
    Monoplane or biplane systems used for diagnostic and interventionist cardiovascular procedures, which have a stand with arm inC suspended from the ceiling 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