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 Ge Healthcare, Division De General Electric Company || Ge Healthcare.

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
    I1505-193
  • Event Number
    2010DM-0006391
  • Date
    2015-05-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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 states that during the acquisition of images could be a blockage in the database, probably causing the lack of images in the exams, compromising its integrity, this would lead to potential delays in diagnoses.

Device

PACS
  • Model / Serial
    Centricity, software versions 3.7.1.1 to 3.7.3.9Sp1, 3.7.3Spa10 and 4.0.1
  • Product Description
    The digital archiving of medical images and as well as for their administration and transmission to other dedicated visualization stations or between them through a computer network. The PACS also allows to make consultations with specialists in other locations outside the institution via web / internet for authorized physicians, protecting the privacy of the patient and the integrity of the data. Among the medical images that can be archived and administered by the PACS are imaging results from: nuclear medicine, computed tomography (CT), computerized radiography (CR), digital radiography (RD), DEXA (DX), special procedures and 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. It is noted that the PACS system has no contact with the patient or controls any 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 measurements, cross references, adjust windows, synchronize and re-position the images and see them dynamically. It is also possible to print, copy and e-mail the images and studies, including the Internet for authorized clinical users.
  • Manufacturer
    Ge Healthcare, Division De General Electric Company || Ge Healthcare

Manufacturer

Ge Healthcare, Division De General Electric Company || Ge Healthcare