Events

Safety Alert for Equipment for Computerized Tomography

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 Israel - Functional Imaging || Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hang Wei 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
    I1605-178
  • Event Number
    2007EBC-0000590
  • Date
    2016-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 the service procedure describing the replacement of a power supply on the rotation side of the gantry specifies the incorrect torsion for the mounting hardware, due to this error, the three decelerating bolts that adjust the power supply could have an excess of if the torque has been replaced in your system, in the unlikely event that the bolts fail in the scanner's gantry during operation, serious bodily injury could result if the component is fired, which could lead to potentially occurring adverse events about patients.

Device

Equipment for Computerized Tomography

Manufacturer

Ge Medical Systems Israel - Functional Imaging || Ge Medical Systems, Llc. || Ge Healthcare Japan...