Events

Safety Alert for Vascular and Gynecological Doppler VIASYS NEUROCARE

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

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
    R1707-277
  • Event Number
    2008EBC-0002443
  • Date
    2017-07-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=79
  • 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 identified that the referenced probes can present excessive background noise that can mask the test results and decrease the ability of the user to clearly hear the heart rate or blood flow, leading to possible adverse events on the patient oprolongation of the examination time .

Device

Vascular and Gynecological Doppler VIASYS NEUROCARE
  • Model / Serial
    reference probes, NW20, N200, N300, N500.
  • Product Description
    Diagnosis and monitoring of the vascular and obstetric system.
  • Manufacturer
    Natus Neurology Incorporated

Manufacturer

Natus Neurology Incorporated