Events

Rappel de CSeries Clinac, Trilogy and Novalis Tx

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Varian Medical Systems Oncology Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53778
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0910-2011
  • Date de mise en oeuvre de l'événement
    2009-10-08
  • Date de publication de l'événement
    2011-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86503
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
  • Action
    Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.

Device

CSeries Clinac, Trilogy and Novalis Tx
  • Modèle / numéro de série
    to be added.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. || Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Adresse du fabricant
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA