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
    58256
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2596-2011
  • Date de mise en oeuvre de l'événement
    2007-11-30
  • Date de publication de l'événement
    2011-06-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98822
  • 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: when a plan is sent to focal from xio and the structure properties are edited in focal ct sim activity, these changes result in changes to the mlc or field size for the plan when they should not. xio will recalculate dose when modified plan is returned to xio however the user may not notice that it has changed form the plant they had approved earlier. editing the structure properties (col.
  • Action
    Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.

Device

Device Recall Focal Radiation Treatment Planning System
  • Modèle / numéro de série
    Focal Release 4.3.0 through 4.34.01
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Turkey, United Kingdom, Uruguay, and Venezuela.
  • Description du dispositif
    Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 || 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