Events

Retiro De Equipo (Recall) de GE Giraffe Infant Warmers with blenders

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Ohmeda Medical 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
    15897
  • Fecha de inicio del evento
    2013-12-18
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The manufacturer has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/o2 gas mixture from the unit.
  • Acción
    Product to be modified

Device

GE Giraffe Infant Warmers with blenders
  • Modelo / Serial
    Model: All models with blender, Affected:
  • Manufacturer
    Ohmeda Medical Inc

Manufacturer

Ohmeda Medical Inc