Events

Safety Alert for IMPAX – PACS and RIS AGFA

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

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
    I1402-92
  • Event Number
    INVIMA 2012DM-0009238
  • Date
    2014-02-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=207
  • 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 the software could visualize and print the name of a patient about a study that does not correspond, this error affirms it is related to the gluing impression of microsoft word, leading to the potential occurrence of adverse events on the patient.

Device

IMPAX – PACS and RIS AGFA
  • Model / Serial
    IMPAX RIS QDoc Software version 5.8 and later
  • Product Description
    The IMPAX RIS (radiology information system) system manages all radiology tasks electronically, from the beginning to the end, including requesting and scheduling examinations, creating protocols, registering patients, establishing work lists, preparing medical reports, transcription , business intelligence and distribution of results.
  • Manufacturer
    AFGA Healthcare NV

Manufacturer

AFGA Healthcare NV