Events

Rappel de Varian brand 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
    63093
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2462-2012
  • Date de mise en oeuvre de l'événement
    2012-08-17
  • Date de publication de l'événement
    2012-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112531
  • 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
    Varian has identified an anomaly with the eclipse treatment planning where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the database/system server. treatment of the patient using these values can therefore lead to under or over-dose.
  • Action
    VARIAN Medical Systems sent an Urgent Medical Device Correction Urgent Field Safety Notice on August 17, 2012, to all affected customers with a description of the problem and user corrective action steps. Customers were instructed to ensure that the workstation clock be synchronized with the DatabaseSystem server clock. Customers were also instructed to contact Varian service for assistance with time synchronization if required. Customers were to complete the attached Proof of Notification Form once they have read the document and return it to Varian Medical Systems. For questions customers should call the following numbers: USA and Canada 1-888-827-4265. Europe +41 41 749 8844. For questions regarding this recall call 650-424-5731.

Device

Varian brand Eclipse Treatment Planning System
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally. . .
  • Description du dispositif
    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 || Reference/FSCA Identifier: CP-08922; 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 algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
  • 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