Events

Retiro De Equipo (Recall) de Centricity Enterprise Archive 4.0

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 It.

¿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
    64760
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0833-2015
  • Fecha de inicio del evento
    2013-04-19
  • Fecha de publicación del evento
    2014-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117004
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • Causa
    Ge healthcare has become aware of a potential data loss issue associated with empty path names resulting from hl-7 updates when the cache disk is almost full.
  • Acción
    General Electric sent an Urgent Medical Device Correction letter dated April 19, 2013, to all affected customers. The letter instructs customers to ensure that Enterprise Archive partitions have enough free space available, in particular the cache disk should have at least 10% free space available. This could be facilitated by setting appropriate disk limits and watermarks on the individual libraries in Enterprise Archive. In case the disks are not being purged to the configured watermarks and the cache disk is almost full, customers are requested to contact their local GE service person. A permanent product correction will be provided to all customers under FMI85209R. Customers with questions were instructed to contact their local Sales/Service Representative. Also the Remote Online Center (ROC) Customer Care can be reached at 1-800-437-1171.

Device

Centricity Enterprise Archive 4.0
  • Modelo / Serial
    Centricity Enterprise Archive versions: 4.0.x
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, OH, WA.
  • Descripción del producto
    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).
  • Manufacturer
    Ge Healthcare It

Manufacturer

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