Events

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

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
    57379
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1245-2011
  • Fecha de inicio del evento
    2010-12-03
  • Fecha de publicación del evento
    2011-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96005
  • 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
    The ge centricity laboratory system software has safety issues with the "telephone list" function, the "anatomic pathology" application, and the instrument interface io module that may impact patient safety.
  • Acción
    GE Healthcare, sent "Urgent Medical Device Correction" letters dated December 12, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the product, the problem, and the action to be taken by the customer. The letters provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.

Device

Device Recall GE Centricity Laboratory
  • Modelo / Serial
    Software versions 3.x and 4.x
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OR, TN, VA, and WI, , and internationally to the countries of Australia, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
  • Descripción del producto
    GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used 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. || The Centricity Laboratory software is used 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 report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results.
  • 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