Events

Safety Alert for Ultrasound diagnostic system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hitachi Aloka Medical 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
    I1604-147
  • Event Number
    2009DM-0003829
  • Date
    2017-04-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • 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 the screen arm screws for the referenced medical devices, where the 21-inch monitors are supported, may be loosened due to a design defect and as a result the screen and monitor may come off, which could lead to potentially delaying the attention of patients or adverse events on users.

Device

Ultrasound diagnostic system
  • Model / Serial
    ARIETTA 60 and 70, specific serials.
  • Product Description
    It is used by general practitioners and professionals specialized in the areas of radiology, obstetrics, gynecology, cardiology, urology, gastroenterology, endoscopy, among others; to perform diagnostic imaging studies porultrasonido.
  • Manufacturer
    Hitachi Aloka Medical Ltd

Manufacturer

Hitachi Aloka Medical Ltd
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    NIDFSINVIMA