Events

Rappel de Centricity Cardio Imaging

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 It.

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
    64787
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0034-2014
  • Date de mise en oeuvre de l'événement
    2012-10-02
  • Date de publication de l'événement
    2013-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117071
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Ge healthcare is aware of a potential safety risk where an image labeling situation exists in the image viewer software of the centricity cardio imaging product, version 5.0 sp1. multiple studies may be displayed side by side by selecting "compare study" from the study list, or by opening prior studies in the patient folder. in these cases, the viewer differentiates the studies wityh a label (curr.
  • Action
    GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future. Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171.

Device

Centricity Cardio Imaging
  • Modèle / numéro de série
    Software Version: 5.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the state of OK
  • Description du dispositif
    Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). || Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
  • Manufacturer
    GE Healthcare It

Manufacturer

GE Healthcare It
  • Adresse du fabricant
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA