Events

Retiro De Equipo (Recall) de Device Recall Centricity Perinatal and Centricity Intensive Care

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
    64805
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0337-2014
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-11-18
  • 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=117104
  • 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
    System, monitoring, perinatal - Product Code HGM
  • Causa
    1) under rare network conditions, a centricity perinatal process may maintain an incorrect count of patient slots in use which may lead to an inability to access the patient roster. the user is temporarily unable to review or edit form and chart information. this could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) when.
  • Acción
    GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 11, 2013, to all affected customers. The letters requested that direct accounts ensure that all potential users of the software were made aware of the potential problems and the recommended actions. Direct accounts were asked to return a customer response form and to return it to GE Healthcare via fax at 847-939-1522 or e-mail at QARAFMl1@ge.com. Version 6.94 of the software has been modified to correct these defects. GE Technical Support: 800-433-2009.

Device

Device Recall Centricity Perinatal and Centricity Intensive Care
  • Modelo / Serial
    Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.
  • Descripción del producto
    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.
  • 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