Retiro De Equipo (Recall) de GE Service Kits (containing the Drive Gas Check) for Anaesthesia Work Stations

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 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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 drive gas check could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. if this issue is left unresolved it could result n excessive or prolonged pressure in the patient breathing circuit during ventilatoin potentially resulting in barotrauma.There have been no injuries reported as a result of this issue.
  • Acción
    Product to be modified


  • Modelo / Serial
    Model: 1009-8216-000, 1503-3006-000, 1503-8102-0000, 1009-8423-000 and 1503-8101-000., Affected:
  • Manufacturer