Events

Safety Alert for file system and transfer of medical images

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fujifilm Corporation || Fujifilm Techno Products 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
    I1611-502
  • Event Number
    2009DM-0004506
  • Date
    2016-11-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • 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 during the sending of an fcr image to a pacs from another manufacturer, that the images of a patient were assigned to a different patient, leading to potentially adverse events occurring on the patients.

Device

file system and transfer of medical images
  • Model / Serial
    SYNAPSE, software version 4.0, 4.1, 4.2 and 4.3
  • Product Description
    Software and hardware for the storage, transfer and processing of diagnostic images from different imaging equipment such as resonance imaging, tomographs, X-ray equipment, ultrasound, and nuclear medicine equipment, in order to allow diagnosis by the treating physicians and the departments of Medical diagnostic.
  • Manufacturer
    Fujifilm Corporation || Fujifilm Techno Products Co, Ltd

Manufacturer

Fujifilm Corporation || Fujifilm Techno Products Co, Ltd