Events

Safety Alert for X-ray system mobile arches in C

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda.

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
    I1610-441
  • Event Number
    2009EBC-0003260
  • Date
    2016-10-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=117
  • 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 if before or during a procedure, the c-arm moves up or down without pressing, it must press the emergency stop button and suspend the use of the equipment, this failure would lead to potential serious adverse events being presented. the patients or users.

Device

X-ray system mobile arches in C
  • Model / Serial
    BRIVO OEC 715, BRIVO OEC 785 and BRIVO OEC 865, specific serials.
  • Product Description
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operation or examination table, based on x-ray technology that allows: obtaining and / or recording of fixed images (conventional radiography and digital) of internal body structures by exposing a part of the body to a small dose of x-ray radiation; obtaining and / or recording moving images in real time (continuous, pulse or snapshot fluoroscopy) and taking video of the patient's internal structures as support for diagnostic, surgical procedures and intervention procedures. These equipments are designed to visualize anatomical structures converting a radiation pattern x into a visible image through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, vascular and cardiac neurology including implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, vessel angiography of legs, heart and brain, and can be used for other imaging applications at the doctor's discretion.
  • Manufacturer
    GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda

Manufacturer

GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE...