Events

Retiro De Equipo (Recall) de Device Recall GE Centricity Web Diagnostic (WebDx)

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 Medical Systems Information T.

¿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
    64545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1782-2017
  • Fecha de inicio del evento
    2013-02-18
  • Fecha de publicación del evento
    2017-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116455
  • 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
    System, image processing, radiological - Product Code LLZ
  • Causa
    It was reported from a complaint that study category labels of "prior" and "baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
  • Acción
    Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.

Device

Device Recall GE Centricity Web Diagnostic (WebDx)
  • Modelo / Serial
    Versions 1.0, 1.1, 2.0, 2.1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Worldwide
  • Descripción del producto
    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
  • Manufacturer
    Ge Medical Systems Information T

Manufacturer

Ge Medical Systems Information T
  • Dirección del fabricante
    Ge Medical Systems Information T, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA