Events

Safety Alert for unkown device

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Welch Allyn Protocol Inc. || Welch Allyn 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
    I1402-60
  • Event Number
    2009EBC-0003199
  • Date
    2014-02-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=210
  • 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
    It is affirmed by the manufacturer that the welchallyn parent company will end with the manufacture and sale of the mentioned references after december 2014, in particular propaq cs with the option of co2 was suspended since january 24, 2014, however, informs that it will continue to provide support and technical service for up to five (5) more years or until the spare parts and accessories are exhausted.

Device

unkown device
  • Model / Serial
    ACUITY CENTRAL, MICROPAQ, MOBILE ACUITY LT, PROPAQ CS, COMMUNICATION SERVER (WACS), PROPAQ || LT and 1500
  • Product Description
    Electronic device that captures and amplifies the electrical activity of the heart through electrodes placed in the 4 extremities and in 6 positions in the chest, measures the average arterial pressure, the pulse, the oxygen saturation and the temperature.
  • Manufacturer
    Welch Allyn Protocol Inc. || Welch Allyn Inc

Manufacturer

Welch Allyn Protocol Inc. || Welch Allyn Inc