Events

Safety Alert for PRIMUS / ONCOR Linear Accelerator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Medical Solutions Usa, 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
    I1509-434
  • Event Number
    2008EBC-0001814
  • Date
    2015-09-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=171
  • 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 has determined that there may be a problem in the mosaiq software, related to the configuration of the operating system of windows and mosaiq, resulting in the display of incorrect decimal symbols and / or unintentional omitting of numerical data that are factors of 10, as well inconsistencies in the date and time formats, resulting in possible alterations of geometric parameters affecting the dose and the time of exposure of the patient to the radiation, which could lead to the occurrence of potentially adverse events on the patient.

Device

PRIMUS / ONCOR Linear Accelerator

Manufacturer

Siemens Medical Solutions Usa, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA