Events

Rappel de Device Recall XiO RPT 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 Elekta, 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
    67625
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1197-2014
  • Date de mise en oeuvre de l'événement
    2014-02-17
  • Date de publication de l'événement
    2014-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125859
  • 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
    Dose and monitor unit values are not computed correctly when elekta motorized wedges are used with dynamic conformal arcs.
  • Action
    Elekta, Inc. issued an Important Safety Notice (LINXi000019) issued February 14, 29, 2014. The Safety Notice identified the product, the problem, and the action to be taken by the customer. All affected customers of the issue globally by February 28, 2014. Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix. Version 5.00.01 will be released for the fix in March 2014. Follow up with the affected customers for confirmation receipt of the LIN, and confirmation of installation of patch for the fix by November 30, 2014. For questions regarding this recall call 770-670-2422.

Device

Device Recall XiO RPT System
  • Modèle / numéro de série
    Versions 4.1 and higher
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and Internationally to Albania, Algeria, Argentina, Australia, Austria, Bahamas, Barbados, Bermuda, British Guiana, Boliva, Brazil, British West Indies, Burundi, Canada, Chile, China, Columbia, Costa Rica, Cuba, Curacao, Cyprus, Czechoslovakia, Dominica, Equator, Estonia, Egypt, Finland, France, Gambia, Germany, Great Britain, Georgia, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lativa, Lithunia, Madagascar, Malaysia, Malta, Mexico, Mongolia, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, San Salvador, Saudia Arabia, Serbia, Singapore, Sir Lanka, South Korea, Spain, Sudan Slovenia, Suriname, Tajikistan, Thailand, Turkey, Turkmenistan, Taiwan, Ukraine, Uruguay, Venezuela, Viet Nam, Zambia.
  • Description du dispositif
    XiO RPT System || The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA