Events

Rappel de XiO Radiation 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 Computerized Medical Systems 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
    61746
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1644-2012
  • Date de mise en oeuvre de l'événement
    2012-04-30
  • Date de publication de l'événement
    2012-05-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108860
  • 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
    Xio will underestimate the dose delivered when the closed leaf gap is set to 0mm on xio and a value other than 0mm is set on the accelerator.
  • Action
    Computerized Medical Systems, Inc. sent an Important Safety Notice the week of April 30, 2012, by regional support managers via e-mail, fax, or regular mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. North American customers were instructed to go to www.elekta.com, select the SupportPlus Login at the top of the page, enter their portal, select Downloads/Updates to download the latest patches. For Customers outside North America, go to www.elekta.com, select the SOFTWARE button on the left, Treatment Planning Software, then Contact TPS Support tab, Download TPS Software Patches. ............................................................. Customers were also instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. For questions regarding this recall call 408-380-8023.

Device

XiO Radiation Treatment Planning System
  • Modèle / numéro de série
    Versions 4.30.00, 4.31.00, 4.32.00, 4.33.00, 4.33.01, 4.33.02, 4.34.00, 4.34.01, 4.34.02, 4.40.00, 4.40.04, 4.40.05, 4.41.00, 4.41.01, 4.41.02, 4.42.00, 4.43.00, 4.44.01, 4.44.02, 4.44.03, 4.44.04, 4.45.00, 4.46.00, 4.46.01, 4.47.00, 4.50.00, 4.50.01, 4.50.02, 4.50.03, 4.50.04, 4.51.00, 4.51.01, 4.51.02, 4.60.00, 4.60.01, 4.61.00, 4.62.00, 4.62.01, 4.62.02, 4.62.03, 4.62.04, 4.62.05, 4.62.06, 4.63.00, and 4.64.00.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Description du dispositif
    XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. || 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 plan set-up.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Adresse du fabricant
    Computerized Medical Systems Inc, 13723 Riverport Dr Ste 100, Maryland Heights MO 63043-4819
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA