Events

Rappel de GE Discovery ST (16 Slice) 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 GE Healthcare, LLC.

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
    57193
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0943-2011
  • Date de mise en oeuvre de l'événement
    2010-10-27
  • Date de publication de l'événement
    2011-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95565
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Cause
    Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain ctdi adjustment factors used for the manual calculation from the technical reference manual (trm) are incorrect. ctdi100 aperture adjustment factors for 4x0.625 mode contain incorrect values. this issue may lead to inaccurate ctdi manual calculation. the results of the diffe.
  • Action
    An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.

Device

GE Discovery ST (16 Slice) System
  • Modèle / numéro de série
    Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. || Head and whole body X-ray computed tomography applications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA