Events

Rappel de Device Recall GE OEC 9800

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 GE OEC 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
    62691
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2240-2012
  • Date de mise en oeuvre de l'événement
    2009-11-06
  • Date de publication de l'événement
    2012-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111381
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    Ge oec is recalling certain 9800 image intensified flouroscopic x-ray systems due to customer complaint analysis showing that a replacement hitachi 160 gb hard drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.
  • Action
    GE OEC sent a Urgent Recall Notice dated November 6, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification advised them that GE Healthcare had identified a potential safety issue associated with a "Significant increase on Data Loss, Data Mix, and System file corruption of the Hard Drives" on the 9800 Systems. The field correction consisted of installing a "Smart Power Switch" between the power control PCB and the system power switch on 9800 Systems with a Celeron single board computer and software version 29. This will remedy the potential for data loss, data mix, and system file corruption of the hard drives. For further questions please call 800-874-7378 Option 8.

Device

Device Recall GE OEC 9800
  • Modèle / numéro de série
    Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide)
  • Description du dispositif
    892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Adresse du fabricant
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA