Events

Rappel de Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning

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 Integra LifeSciences Corp..

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
    63856
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1103-2013
  • Date de mise en oeuvre de l'événement
    2012-12-10
  • Date de publication de l'événement
    2013-04-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114917
  • 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
    Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from xknife using dicom-rt.
  • Action
    Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.

Device

Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
  • Modèle / numéro de série
    Software Versions 5.0.1 and 5.0.2.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
  • Description du dispositif
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, || Software Versions 5.0.1 and 5.0.2. || Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.