Events

Rappel de Device Recall 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
    58215
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2568-2011
  • Date de mise en oeuvre de l'événement
    2009-05-13
  • 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=98684
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    System planning radiation therapy treatment - Product Code muj
  • Cause
    In xio, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. this can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.
  • Action
    Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Computerized Medical Systems, Inc have created "patches" to resolve the problem. A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included. For further questions, please call (408) 380-8023.

Device

Device Recall XiO Radiation Treatment Planning System
  • Modèle / numéro de série
    XiO Release 4.3.0 through 4.50.00
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Description du dispositif
    XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
  • 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