Events

Rappel de Device Recall EOS 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 Eos Imaging 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
    62621
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2072-2012
  • Date de mise en oeuvre de l'événement
    2012-06-19
  • Date de publication de l'événement
    2012-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111193
  • 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
    Solid state x-ray imager ( flat panel/digital imager) - Product Code MQB
  • Cause
    It was discovered of several generator failures of the eos system due to failure of its anode controller board that drives the rotation of the x-ray tube anode.
  • Action
    EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.

Device

Device Recall EOS System
  • Modèle / numéro de série
    All associated Serial Numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer
    Eos Imaging Inc

Manufacturer

Eos Imaging Inc
  • Adresse du fabricant
    Eos Imaging Inc, 185 Alewife Brook Pkwy Ste 410, Cambridge MA 02138-1104
  • Société-mère du fabricant (2017)
    EOS Imaging SA
  • Source
    USFDA