Events

Retiro De Equipo (Recall) de Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators

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 Ohmeda Medical, A division of Datex-Ohmeda, Inc..

¿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
    31665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1047-05
  • Fecha de inicio del evento
    2005-04-25
  • Fecha de publicación del evento
    2005-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38318
  • 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
    Incubator, Neonatal - Product Code FMZ
  • Causa
    Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
  • Acción
    Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.

Device

Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Modelo / Serial
    Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
  • Descripción del producto
    Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Manufacturer
    Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Manufacturer

Ohmeda Medical, A division of Datex-Ohmeda, Inc.
  • Dirección del fabricante
    Ohmeda Medical, A division of Datex-Ohmeda, Inc., 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA