Events

Retiro De Equipo (Recall) de Device Recall Centricity TriWin 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 Integrated IT Solutions.

¿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
    50201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1397-2009
  • Fecha de inicio del evento
    2008-11-17
  • Fecha de publicación del evento
    2009-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74977
  • 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
    A software defect in the centricity lab (triwin) product may incorrectly link patient information to a wrong report. also, when viewing results in patient viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.
  • Acción
    GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.

Device

Device Recall Centricity TriWin Laboratory
  • Modelo / Serial
    software version 7.3
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and country of Canada.
  • Descripción del producto
    Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || The Centricity TriWin Laboratory product is a laboratory information system. It 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.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Dirección del fabricante
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA