Events

Rappel de Device Recall Focal 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
    58233
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2572-2011
  • Date de mise en oeuvre de l'événement
    2008-03-31
  • Date de publication de l'événement
    2011-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98778
  • 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
    Focal: in absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and qa plan reflect blocked normalization. this is particularly important when these beams also include compensators. the problem is detectable by looking at the delivered dose to the weight point in the patient as.
  • Action
    Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403) 830-8023.

Device

Device Recall Focal Radiation Treatment Planning System,
  • Modèle / numéro de série
    Focal Release 4.3.1 through 4.34.02
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela.
  • Description du dispositif
    Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. || For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

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