Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.

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 Datex Ohmeda, Inc. dba GE Healthcare.

¿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
    49097
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0305-2009
  • Fecha de inicio del evento
    2008-06-20
  • Fecha de publicación del evento
    2008-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72753
  • 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
    Neonatal lncubator. - Product Code FMZ
  • Causa
    Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
  • Acción
    A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed¿¿ cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual. Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
  • Descripción del producto
    Giraffe OmniBed¿, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • Dirección del fabricante
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA