Events

Rappel de GE Centricity PACS RA1000 Workstation

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 Integrated IT Solutions.

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
    49458
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0460-2009
  • Date de publication de l'événement
    2008-12-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73472
  • 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
    Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving default display protocols (ddps) which are used to layout images when displaying a study. if the user does not check the study date time of the exam on the image title bar, then they may interpret the curr.
  • Action
    GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.

Device

GE Centricity PACS RA1000 Workstation
  • Modèle / numéro de série
    GE Centricity PACS RA1000 Workstation software versions:  1) Software version 2.1.X (from 2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases prior to 2.1.5.1 for the default display protocol issue), and   2) Software version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela.
  • Description du dispositif
    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity" PACS infrastructure.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Adresse du fabricant
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA