Events

Retiro De Equipo (Recall) de Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿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
    RC-2013-RN-00459-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00459-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ge healthcare has determined that the reusable carbon dioxide absorbent canisters from the affected lot may have an undersized groove which does not allow the canister to seal properly resulting in leakage of breathing system gases.
  • Acción
    End users are requested to cease using the carbon dioxide absorbent canister component of their anaesthesia system. Unaffected replacement canisters will be provided by GE Healthcare.

Device

Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Ais...
  • Modelo / Serial
    Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systemsPart Numbers: 1407-3200-000, 1407-7004-000 & M1084850Date Code: 02-2013 (Feb 2013). ARTG number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd