Events

Rappel de Device Recall CyberKnife 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 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
    56326
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0890-2011
  • Date de mise en oeuvre de l'événement
    2010-07-06
  • Date de publication de l'événement
    2011-01-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93237
  • 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
    Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. a design change is planned.
  • Action
    Accuray sent an "URGENT DEVICE CORRECTION" letter dated July 6, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to assure the LINAC cover is secure following reattachment and adhere to and follow the instructions included in the letter. Note: A new design is being developed, and will be distributed to user base once available. 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) or +1-408-716-4700 (non-USA) or customersupport@accuray.com.

Device

Device Recall CyberKnife Treatment Planning System
  • Modèle / numéro de série
    All products are affected.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.
  • Description du dispositif
    CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. || Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    Accuray Inc

Manufacturer

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