Events

Safety Alert for Robotic Radiosurgery System CYBERKNIFE

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

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
    I1602-45
  • Event Number
    2009EBC-0003732
  • Date
    2016-02-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • 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 the support of the structure of the electronic control box of the gun does not support the weight of the electronic control box in vertical position, causing it to loosen, leading to the occurrence of potential adverse events on patients.

Device

Robotic Radiosurgery System CYBERKNIFE
  • Model / Serial
    G4, VSI and G3
  • Product Description
    The CYBERKNIFE robotic radiosurgery system is a non-invasive alternative to surgery for the treatment of cancerous and non-cancerous tumors anywhere in the body, such as the prostate, lung, brain, spine, liver, pancreas and kidney. The treatment - which administers radiation beams through a linear accelerator in high doses to tumors with extreme precision - offers new hope to patients around the world. CYBERKNIFE systems are intended to provide treatment planning and guided image-guided stereotactic radiotherapy and radiotherapy for tumors, injuries and conditions anywhere in the body when radiation treatment is indicated. These systems can be used for traumastrocytoma, glioma, tumors of the base of the skull, metastasis, (cerebral and bone), nasopharyngeal carcinoma, meningioma, acoustic neuroma, vertebral and cavernous malformations, trigeminal neuralgia and tumors of the neck, lung.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    NIDFSINVIMA