Events

Safety Alert for SCHILLER electrocardiographs

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

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
    I1804-270
  • Event Number
    2014DM-0011889
  • Date
    2018-04-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=49
  • 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

Device

SCHILLER electrocardiographs
  • Model / Serial
    AT-102 plus, all serials
  • Product Description
    The electrocardiograph (ECG) is a device that is used to record analyze and evaluate the records of the signal generated by cardiac activity. The records made with the ECG can be used to facilitate the diagnosis of cardiac function and cardiac conditions. The ECG is designed for indoor use and can be used for patients of both sexes, of all races and of all ages.
  • Manufacturer
    Schiller Américas, Inc

Manufacturer

Schiller Américas, Inc