Events

Rappel de Device Recall Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.

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
    57760
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2561-2011
  • Date de mise en oeuvre de l'événement
    2011-01-13
  • Date de publication de l'événement
    2011-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97342
  • 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
    Monaco: for vmat plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in monaco release 2.03.00 and 2.04.00.
  • Action
    Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.

Device

Device Recall Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.
  • Modèle / numéro de série
    Release 2.03.00 and above.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.
  • Description du dispositif
    Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. || The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) 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