Events

Safety Alert for ultrasound systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Philips Ultrasound Inc. || Philips Medical Systems..

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
    I1501-5
  • Event Number
    2008DM-0001665
  • 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 reports that when using qlab automated dequantization applications, the calculated values for some variables may be less than that calculated based on the manual alignment, leading to possible adverse events on patients.

Device

ultrasound systems
  • Model / Serial
    EPIQ7
  • Product Description
    Designed to obtain, treat and analyze internal body images of the patient's body such as muscles, organs, their shape, structures and possible pathologies or injuries through the emission of ultrasound waves and the formation of images from the information contained in the echoes received for diagnostic purposes.
  • Manufacturer
    Philips Ultrasound Inc. || Philips Medical Systems.

Manufacturer

Philips Ultrasound Inc. || Philips Medical Systems.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA