Events

Rappel de Device Recall Monaco RTP 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
    58229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2560-2011
  • Date de mise en oeuvre de l'événement
    2008-06-30
  • 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
    2013-04-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98760
  • 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: if the user selects monte carlo photon as the secondary algorithm (to be used for final dose calculation through segments), and selects skip forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though monte carlo was selected. other than specific output to the console window, there will be no other in.
  • Action
    Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter. This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above. Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.

Device

Device Recall Monaco RTP System
  • Modèle / numéro de série
    XiO Release 1.0.0 through 1.0.2 All lot or serial numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Slovenia, South Korea, Spain, and United Kingdom.
  • Description du dispositif
    Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. || Used to create treatment plans for any cancer patient for who 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