Events

Safety Alert for magnetic resonance equipment

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GE Medical Systems, Llc. || GE Hangwei Medical Systems Co. Ltd || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc (Dba GE Healthcare), || Xinaomdt Technology Co, Ltd || GE Medical Systems Scs || General Medical Merate Spa || GE Healthcare || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda. || GE Medical Systems Technologies 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
    I1411-486
  • Event Number
    2007DM-0001028
  • Date
    2014-11-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=191
  • 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 there is the possibility of an error in the orientation of the images causing their investment, when they are acquired using the option psd bundling with the focus excitation mode, leading to the presentation of possible adverse events on the patients.

Device

magnetic resonance equipment

Manufacturer

GE Medical Systems, Llc. || GE Hangwei Medical Systems Co. Ltd || GE Medical Systems Information ...