Events

Rappel de Device Recall HiArt 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
    59427
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3163-2011
  • Date de mise en oeuvre de l'événement
    2011-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102766
  • 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
    Tomotherapy inc. is sending this field safety notice to make you aware of an anomaly which may affect the performance of the tomomobile hi-art system. tomotherapy has discovered that when attempting to open the tomomobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.
  • Action
    The firm, TomoTherapy, sent an "Urgent Medical Device Correction" letter dated July 7, 2011 to its consignees/customers. The letter described the Issue, Product Affected, Recommended Action (advised consignees to not attempt to open the shielding doors when the hinges are in the locked position. The Hinges should always be in the unlocked position when opening the doors) and Resolution. A TomoTherapy field service engineer or an authorized service representative will contact the customers when a resolution is available. If you have any questions, please contact the TomoTherapy Technical Solutions Center by email at support@tomotherapy.com or phone at: North America: 1-866-368-4807; Belgium: 0800 38783; France: 0805 631 565; Germany: 0800 000 7541; Italy: 800 986 399; Netherlands: 0800 020 1364; Spain: 800 300049; Switzerland: 0800 001927; United Kingdom: 0808 238 6035; China/CNC (Northern): 10 800 712 1701; China (Southern): 10 800 120 1701; Hong Kong: 800 967912; Japan: 0044 22 132374; Singapore: 800 1204 683; South Korea: 0079 81 4800 7204, all other locations: +1 608 824 2900 or +32 2 400 44 44.

Device

Device Recall HiArt System
  • Modèle / numéro de série
    Serial Numbers: 110051 110101 110298 110329
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA and OK; and country of: United Arab Emirates
  • Description du dispositif
    TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 || The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Adresse du fabricant
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • Société-mère du fabricant (2017)
    Accuray Inc
  • Source
    USFDA