Events

Rappel de GE Innova 3100

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 Healthcare.

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
    53260
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1688-2009
  • Date de mise en oeuvre de l'événement
    2008-10-09
  • Date de publication de l'événement
    2009-09-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85118
  • 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 - Product Code MQB
  • Cause
    Ge healthcare has become aware of an air kerma rate issue associated with a large equivalent patient thickness (ept) on the innova system that my impact patient safety. during a maximum air kerma rate (akr) calibration procedure check, ge healthcare found the akr calibration procedure does not exactly reflect the worst-case clinical usage of the product. this may result, when using large equival.
  • Action
    Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.

Device

GE Innova 3100
  • Modèle / numéro de série
    Serial 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and 00000563637BU8.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico and Guam.
  • Description du dispositif
    GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Adresse du fabricant
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA