Events

Retiro De Equipo (Recall) de Device Recall Centricity Web

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare Integrated IT Solutions.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    50540
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0870-2009
  • Fecha de inicio del evento
    2008-12-12
  • Fecha de publicación del evento
    2009-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75718
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Image Communications Device - Product Code LMD
  • Causa
    Software error: there are two potential safety situations with centricity enterprise web software - a forced log off may occur while using the centricity enterprise web during an open session, and centricity enterprise web does not utilize calibration performed on image measurements in centricity ra1000 workstation.
  • Acción
    GE Healthcare Integrated IT Solutions notified their Centricity Enterprise Web software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomalies resulting in patient safety issues involving a forced log off during an open session while using the Centricity Enterprise Web and measurements displayed in Centricity Enterprise Web will use the calibration provided by the original scanning modality. Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed 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 414-918-4653. For further information, please contact GE Customer Care Center by telephone at 800-437-1171.

Device

Device Recall Centricity Web
  • Modelo / Serial
    Software versions 3.0, 3.0.1, 3.0.1.1, 3.0.2, 3.0.3, and 3.0.4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Descripción del producto
    Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Dirección del fabricante
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA