Events

Safety Alert for IMPAX - PACS and RIS (IMPAX RIS)

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
    I1601-3
  • Event Number
    2012DM-0009238
  • Date
    2016-01-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • 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 detected that when the workflow is used extended in 6.5.X impax and on the presentation of embedded reports there is the possibility of loss of report text when validating addenda, this occurs under specific and simultaneous conditions, leading to the potential loss of data. or images.

Device

IMPAX - PACS and RIS (IMPAX RIS)
  • Model / Serial
    IMPAX 6.5.x
  • Product Description
    The IMPAX RIS (RADIOLOGY INFORMATION SYSTEM) system manages all deradiology tasks electronically, from the beginning to the end, including the application and programming of exams, creation of protocols, registration of patients, establishment of work lists, preparation of medical reports, transcription, Businessintelligence and distribution of results.
  • Manufacturer
    Afga Healthcare NV

Manufacturer

Afga Healthcare NV