Safety Alert for ultrasound equipment - Aortascan scanners

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

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
    A1512-570
  • Event Number
    2010DM-0005383
  • Date
    2015-12-10
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 has detected that when using the diagnostic tool to detect abdominal aortic aneurysms (aaa), a measurement of the diameter of the abdominal aorta that can vary in more than one centimeter of the real diameter can be obtained, which can lead to potential serious adverse events. about the patients.

Device

  • Model / Serial
    BLADDER SCAN BVI9600 and AORTASCAN AMI9700
  • Product Description
    In urology, post-void residual measurement, bladder wall thickness and bladder weight measurement. Envascular, measurement of the diameter of the aorta.
  • Manufacturer

Manufacturer