Events

Retiro De Equipo (Recall) de Arjo-Huntleigh Concerto & Basic Shower Trolleys

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
    20193
  • Fecha de inicio del evento
    2016-05-25
  • 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 have been a number of complaints where the bolts under the stretcher have become loose. there has been one minor injury as a result of a patient falling related to these incidents. manufacturer investigated the issue and the conclusion was that he stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher-tilt function may not engage properly, resulting in a patient falling to the floor., the issue relates to a batch of devices manufactured between 7th march 2014 and 20th april 2015.
  • Acción
    Product to be modified

Device

Arjo-Huntleigh Concerto & Basic Shower Trolleys
  • Modelo / Serial
    Model: , Affected: batch of devices manufactured between 7th March 2014 and 20th April 2015.
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

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