Events

Rappel de Device Recall 4D Intergrated Treatment Console

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
    58230
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2119-2011
  • Date de mise en oeuvre de l'événement
    2011-02-28
  • Date de publication de l'événement
    2011-04-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98761
  • 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
    A software anomaly, in that the multileaf collimator (mlc) message displayed on the 4ditc on versions 8.6 and below, does not interlock beam delivery.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers. Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com. This design fix in 4DITC v10.1 or later will be provided to all affected sites. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager. USA and Canada - 1-888-VARIANS (888-827-4265) Europe - + 41 41 749 8844

Device

Device Recall 4D Intergrated Treatment Console
  • Modèle / numéro de série
    Affected Serial Numbers:  H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.
  • Description du dispositif
    The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
  • 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