Events

Safety Alert for PACS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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 Number
    2010DM-0006391
  • Date
    2018-02-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=54
  • 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

PACS
  • Model / Serial
    Centricity Pacs IW
  • Product Description
    The GE-HEALTHCARE PACS are designed for the digital archiving of medical images and for their administration and transmission to other stations of dedicated display computers or between them through a computer network. PACs also allow consultations with specialists in other locations outside the institution via web / internet for authorized physicians, protecting patient privacy and the integrity of data. Medical images that can be archived and administered by the PACS include imaging results from: nuclear medicine, computed tomography (CT), computerized radiography (CR), digital radiography (RD), DEXA (DX), special procedures and interventional radiography, ultrasound, mammography , among other examinations, it also allows the archiving and administration of data in wave form, documents and patient data including all the functions that are needed to access and manage the studies. He noted that the PACS system does not have contact with the patient or control a device on which life depends. It only constitutes a support on which the doctors interpret the images and information that is being shown on screen or printed through their competent human and professional intervention. It includes a set of software tools that allow you to make measurements, add cross references, adjust the windows, synchronize and re-position the images and view them dynamically. It is also possible to print, copy and send by electronic mail the images and studies, even via the internet for authorized clinical users.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA