Events

Retiro De Equipo (Recall) de ArjoHuntleigh Contoura 1000 & 1080 Bariatric Beds

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 ArjoHuntleigh 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
    15517
  • Fecha de inicio del evento
    2013-10-18
  • 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: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • Causa
    There is a low but existing entrapment risk for a patient being treated of this bed while being under a bmi of 40. small, lightweight patients are at a greater risk of entrapment because their small physical dimensions may enhance their ability to fit into a gap, in whole or in part.
  • Acción
    Instructions for use to be updated

Device

ArjoHuntleigh Contoura 1000 & 1080 Bariatric Beds
  • Modelo / Serial
    Model: Models: 1000 & 1080, Affected: All serial numbers
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

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