Events

Safety Alert for Ultrasound Equipment

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 || Sanmina-Sci Systems Singapore Pte 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 ID
    I1602-80
  • Event Number
    2009DM-0004842
  • Date
    2016-02-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 the automated 2d quantification (a2dq) and automated quantification of cardiac movement (acmq) applications to calculate the end-of-systole volume (vfs), the reported vfs may be less than that calculated by manual tracking without the software, the philips research found that these differences can occur when the ef is less than about 40%, leading to potential adverse events occur on patients or users.

Device

Ultrasound Equipment

Manufacturer

Philips Ultrasound Inc. || Philips Medical Systems || Sanmina-Sci Systems Singapore Pte Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA