Events

Alerte De Sécurité sur Robotic Radiosurgery System CYBERKNIFE

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Accuray Incorporated.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1602-45
  • Numéro de l'événement
    2009EBC-0003732
  • Date
    2016-02-04
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    G4, VSI and G3
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Accuray Inc
  • Source
    NIDFSINVIMA