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 General Medical Merate Spa || GE Healthcare || GE Medical Systems Scs || GE Medical Systems Technologies Co Ltd || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc. || Xinaomdt Technology Co, Ltd || GEHangwei Medical Systems Co. Ltd || GE Medical Systems, Llc (Dba Ge Healthcare), || GE Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || GE Healthcare (Tianjin) Company Limited.

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
    I1702-47
  • Event Number
    2007DM-0001028
  • Date
    2017-02-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 it has detected a possible event of thequench of the magnet with the subsequent release of the cryogenic gas in the magnet room, the cryogenic gas that is released in the room could cause critical deprivation of oxygen, leading to potential adverse events being presented serious about the patients or users.

Device

magnetic resonance equipment

Manufacturer

General Medical Merate Spa || GE Healthcare || GE Medical Systems Scs || GE Medical Systems Techn...
  • Source
    NIDFSINVIMA