Events

Retiro De Equipo (Recall) de Device Recall Centricity Laboratory System

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
    64807
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0620-2014
  • Fecha de inicio del evento
    2013-03-12
  • Fecha de publicación del evento
    2014-01-02
  • 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=117106
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    Ge healthcare is aware of a potential safety issue with the use of ge centricity laboratory instrument interface (if) where free-text sent from im is not being transcribed into free-text in inet. the instrument may upload results to if/inet when order/request is not yet in if/inet. in such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
  • Acción
    GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers. The letter notified customers of the problem, suggested that customers experiencing this problem should retransmit the result from the instrument once the order exists in iNET and verify that the item level free-text is present in iNET, and to contact their GE service representative to request or install the updated software. Customers with additional questions can contact the GE Healthcare IT Help Desk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-589-8496.

Device

Device Recall Centricity Laboratory System
  • Modelo / Serial
    Software Versions: 3.3, 4.0, 4.1
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.
  • Descripción del producto
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. || The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
  • 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