Events

Rappel de Device Recall 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 Incorporated.

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
    61045
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1098-2012
  • Date de mise en oeuvre de l'événement
    2012-01-16
  • Date de publication de l'événement
    2012-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107168
  • 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
    An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4d ray tracing dose calculation algorithm. as a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
  • Action
    Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • Modèle / numéro de série
    Model number: P/N 025153
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece, Saudi Arabia, Switzerland, Ukraine, Czech Republic, and Japan.
  • Description du dispositif
    CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. || Accuray Incorporated, Sunnyvale, CA. || 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 Incorporated

Manufacturer

Accuray Incorporated
  • Adresse du fabricant
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Société-mère du fabricant (2017)
    Accuray Inc
  • Source
    USFDA