Events

Retiro De Equipo (Recall) de Device Recall GE Centricity PACS RA1000 Workstation

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
    50759
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0970-2009
  • Fecha de inicio del evento
    2008-11-20
  • Fecha de publicación del evento
    2009-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76984
  • 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
    Picture Archiving and Communication System - Product Code LLZ
  • Causa
    Unread exams may inadvertently get marked as dictated in pacs workstation when the user signs off the report in talkstation and opens the next exam.
  • Acción
    GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. 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 847-939-1479.

Device

Device Recall GE Centricity PACS RA1000 Workstation
  • Modelo / Serial
    Software versions 2.1.X and 3.0.X and higher with Talk Extend
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.
  • Descripción del producto
    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. 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
  • Dirección del fabricante
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA