Events

Retiro De Equipo (Recall) de Getinge 46 Series Washer Disinfector with PACS 300 module

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 Getinge Disinfection AB.

¿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
    15585
  • Fecha de inicio del evento
    2013-11-06
  • 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • 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 serious injury such as 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
    Product to be modified

Device

Getinge 46 Series Washer Disinfector with PACS 300 module

Manufacturer

Getinge Disinfection AB
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA