Events

Safety Alert for X-ray mobile system DRX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Carestream Health Inc.

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
    I1412-506
  • Event Number
    2014EBC-0011719
  • Date
    2014-12-04
  • 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 it has been identified that the arm-arm assembly may suffer loosening caused by incorrect arm assembly that holds the rx tube, leading to possible adverse events on the patients.

Device

X-ray mobile system DRX
  • Model / Serial
    DRX Revolution, serial 101 to 764
  • Product Description
    X-ray mobile equipment for radiographic applications in hospitals, operating theaters, intensive care, emergencies and out-of-hospital applications (mobile unit) for the taking of medical images for diagnosis through the production and reception of X-rays.
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    NIDFSINVIMA