Events

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

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
    55868
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2067-2010
  • Fecha de inicio del evento
    2010-05-26
  • 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=92102
  • 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
    There is a potential safety issue associated with the use of ge centricity laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. this happens when the test is set up in centricity laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in the result field.
  • Acción
    The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated May 26, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue involving results from interfaced external reference laboratories that are not displayed or stored correctly if an unexpected alpha character is encountered in a result message that is expected to have a numeric value. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the result sent from the reference lab includes a comma in the result field. The letters provided the users with specific safety instructions to follow until the software is 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 the their GE Service Representative or the GE Helpdesk at 888-778-3375.

Device

Device Recall GE Centricity Laboratory Software
  • Modelo / Serial
    All versions and releases
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
  • Descripción del producto
    GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, 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.
  • 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