Events

Retiro De Equipo (Recall) de Maquet operating table accessories

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 Maquet GmbH & Co KG.

¿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
    20675
  • Fecha de inicio del evento
    2016-09-26
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Causa
    Investigation has identified that the raw material of the accessory adapter does not meet specifications. the tensile and the flexural strength of the used material are less than those of the specified materials. serious injury may occur should the attached accessory release from the adapter without warning during a surgical procedure.
  • Acción
    Product to be exchanged

Device

Maquet operating table accessories
  • Modelo / Serial
    Model: , Affected: Accessory Adaptor (600525A0)
  • Manufacturer
    Maquet GmbH & Co KG

Manufacturer

Maquet GmbH & Co KG
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA