Events

Rappel de CyberKnife Robotic Radiosurgery 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 Accuray Inc.

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
    57236
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0714-2011
  • Date de mise en oeuvre de l'événement
    2010-10-28
  • Date de publication de l'événement
    2010-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95637
  • 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
    If users modify the dose calculation box to cover just the contoured anatomy and not the entire ct volume, dosage may not be properly calculated.
  • Action
    Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: customersupport@accuray.com.

Device

CyberKnife Robotic Radiosurgery System
  • Modèle / numéro de série
    All versions
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.
  • Description du dispositif
    CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. || Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Inc

Manufacturer

Accuray Inc
  • Adresse du fabricant
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Source
    USFDA