Events

Safety Alert for angiograph

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Xpro Sistemas Ltda || GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd.

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
    I1611-511
  • Event Number
    2009EBC-0003319
  • Date
    2016-11-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • 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 reports that there is a possibility that the system will not boot properly after a power-up reset, and may also be blocked unexpectedly during an exam, which may cause the total loss of the interventional imaging function in real time. lead to the occurrence of potential adverse events on patients.

Device

angiograph
  • Model / Serial
    Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100 and Innova 4100 IQ with PDB
  • Product Description
    These devices are designed to visualize internal anatomical structures of the patient by converting the pattern of x-ray radiation into a visible image through electronic amplification and radiological visualization of the heart, blood vessels or lymphatic system during or after injection of contrast medium. They are indicated for use in procedures such as diagnosis and intervention of vascular angiography for the generation of fluoroscopic images of human anatomy, rotation exploration, cardiology and others.
  • Manufacturer
    Xpro Sistemas Ltda || GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd

Manufacturer

Xpro Sistemas Ltda || GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd