Events

Rappel de Eclipse Treatment Planning System

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, Inc. 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
    60441
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0370-2012
  • Date de mise en oeuvre de l'événement
    2011-10-31
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105415
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • Cause
    An anomaly has been identified with varian eclipse and rt chart where adding a reference point in rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse.
  • Action
    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice. .

Device

Eclipse Treatment Planning System
  • Modèle / numéro de série
    CODES: All codes from H480005 through H48C896
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An || Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart || module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

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