Events

Safety Alert for Brachytherapy Systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global 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
    I1512-595
  • Event Number
    2009EBC-0003715
  • Date
    2015-12-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 detected that when using the option of overlapping tumor fraction in planning with vmat, the system includes a surrounding organ in the destination volume, resulting in an overdose of radiation, leading to potentially adverse events occurring on the patient.

Device

Brachytherapy Systems
  • Model / Serial
    Oncentra External Beam, concerning the VMAT module with software version 3.3
  • Product Description
    Indicated for an operator to apply, by remote control, a radioactive source in the body by interstitial, intracavitary, intraluminal, bronchial, endovascular, intraoperative applicator, radiation therapy for the treatment of cancer. Applicators and transfer tubes, an integral part of the system The brachytherapy is used to apply the radiation directly to the patient in the specific sites selected by the doctor and they are the only part of the system that has contact with the patient.
  • Manufacturer
    Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global Inc

Manufacturer

Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global Inc
  • Source
    NIDFSINVIMA