Events

Rappel de Elekta Synergy XVI R4.5

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 Elekta, 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
    57960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1723-2011
  • Date de mise en oeuvre de l'événement
    2010-10-25
  • Date de publication de l'événement
    2011-03-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97838
  • 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
    Medical charged-particle radiation therapy system. - Product Code IYE
  • Cause
    If another patient is selected on the imaging system (xvi) release 4.5) during the transmission of end of treatment data from desktop pro r7.01 to r&v; system, the xvi information is prioritized and the end of treatment data is never received by the r&v; system.
  • Action
    Important Notice A341 titled "Mandatory Upgrade Desktop Pro R7.01 Service Pack and Cancelled Notices" dated January 26, 2011, is in distribution to all affected customers. Field Change Order 20000501011, "Service Pack 2 upgrade to Desktop Pro R7.01 Service Pack 1", dated October 25, 2010 will be utilized by Elekta Service personnel to upgrade the Desktop Pro to include Service Pack 2. The Important Notice letter instructed customers to file the letter in the Important Notice section of the appropriate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their treatment control system. If it is not installed, customers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and should be removed from the User Manual. Customers should direct their questions to their local Elekta representative.

Device

Elekta Synergy XVI R4.5
  • Modèle / numéro de série
    Serial Numbers 152019, 152117, 151566, 152271, 151942, 152116, 151141, 151885, 152211, 152214, 152158, 151628, and 152207.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.
  • Description du dispositif
    Elekta Synergy XVI R4.5 || Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA