Events

Retiro De Equipo (Recall) de Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2016-RN-01216-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-09-15
  • 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-2016-RN-01216-1
  • 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
    The manufacturer has become aware that due to a software issue, if the compressed air supply of the machine is lost right before or during product supply (dlc detergent, aperlan poka-yoke agent a/b disinfectant), and after cycle start, and not re-established before cycle end, the machine does not launch or complete the product supply when reprocessing a scope. as a result, no alarm is triggered.
  • Acción
    Getinge is advising users of interim instructions to follow. Users are advised to carefully examine the printer ticket at the end of each reprocessing cycle to ensure there are 3 lines printed for DLC weight, Disinfectant A and B weights are OK. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 20/02/2017.

Device

Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)
  • Modelo / Serial
    Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)Model Number: 01280010Serial Numbers: 4H120383, 4H120384ARTG Number: 228574
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA