Events

Safety Alert for Image Suite Software

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Orex Computed Radiography Ltd || Carestream Health Ltd || Rayco (Shanghai) Medical Products 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
    I1607-273
  • Event Number
    2012DM-0008595
  • Date
    2016-07-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 the possibility that the superimposed text of the i / d and a / p values corresponding to the identification of laterality and position of the image, are shown inverted in the images of computerized tomography and magnetic resonance that are received in the image image software. , leading to confusions of medical personnel and potentially adverse events on patients when erroneous readings of the obtained images are made.

Device

Image Suite Software

Manufacturer

Orex Computed Radiography Ltd || Carestream Health Ltd || Rayco (Shanghai) Medical Products Compa...
  • Source
    NIDFSINVIMA