Events

Retiro De Equipo (Recall) de Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)

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-2013-RN-01075-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-21
  • 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-01075-1
  • 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
    Investigations have shown that the overheating protection system of the heating element may fail to function under certain circumstances. this could result in a burn or respiratory complications as a result of inhaling smoke. the reported overheating events have been confined to the machines. therefore, the probability of occurrence of harm to person based on available evidence is considered remote.
  • Acción
    Getinge is advising customers that a customer service representative will be contacting users to replace the affected overheating protective system. Given the low probability to harm, Getinge is advising that it is considered safe for a normal user who services and uses the machine as intended to continue using the machines while waiting for replacement.

Device

Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination ...
  • Modelo / Serial
    Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)Manufactured between 2004 and 2008ARTG Number: 125655
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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