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
    I1502-64
  • Event Number
    2009EBC-0003732
  • Date
    2015-02-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 a software update should be performed for versions 8.0 that have the first generation of variable aperture collimator, since there was no linear relationship between the opening field of the collimator jaws and the size of the beam, an important relationship in the calculation of accuracy of the dose, leading to potentially serious adverse events occurring on the patient.

Device

Robotic Radiosurgery System CYBERKNIFE
  • Model / Serial
  • Product Description
    Linear accelerator in high doses to tumors with extreme precision - offers new hope to patients all over 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 tracheatrocytoma, 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 and lung.
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    NIDFSINVIMA