Events

Safety Alert for Ultrasound

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Toshiba Medical Systems Manufacturing Asia Sdn. Bhd || Toshiba Medical Systems Corporation.

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
    I1706-249
  • Event Number
    2008DM-0002313
  • Date
    2017-06-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • 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 he has identified the possibility during the measurement of the spectral envelope plot (itv) when this is done manually with the "continuous track" tool, the mpg value (mean pressure gradient) can be shown lower than the value obtained with the "points of the plot" in the tool of sound and the model of the work station referenced, with these results could be deduced an incorrect final diagnosis, leading to the occurrence of possible adverse events on the patient.

Device

Ultrasound

Manufacturer

Toshiba Medical Systems Manufacturing Asia Sdn. Bhd || Toshiba Medical Systems Corporation
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    NIDFSINVIMA